G2 FILTER
Report
- Report Number
- 2020394-2019-00384
- Event Type
- Malfunction
- Date Received
- April 16, 2019
- Report Date
- January 18, 2022
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H10: OF THE THIRTY REPORTED MALFUNCTIONS, 7 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS SERIOUS INJURY AND WERE REPORTED UNDER EMDRS 2020394-2020-06497, 2020394-2020-06505, 2020394-2021-80186, 2020394-2021-80183, 2020394-2021-80288, 2020394-2021-80301, AND EMDR CHILD REC 1748316. ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A DEATH AND WERE REPORTED UNDER EMDR 2020394-2019-04779. H10: OF THE REMAINING 22 MALFUNCTIONS, PRODUCT CATALOG NUMBER OF THREE MALFUNCTIONS UPDATED TO RF320J, TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO UNKNOWN FILTER, ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO RF400J (G2X FILTER) AND TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F (G2X FILTER). H10: THE LOT NUMBER WAS PROVIDED FOR EIGHT MALFUNCTIONS AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 21 MALFUNCTIONS AND TEN OF THE RECORDS INCLUDED IMAGES FOR REVIEW. SEVEN MALFUNCTIONS WERE CONFIRMED FOR THE ALLEGED FILTER PERFORATION AND TILT. ONE MALFUNCTIONS ARE INCONCLUSIVE FOR FILTER PERFORATION AND TILT. TWO MALFUNCTIONS CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT. FOR THREE MALFUNCTION, INVESTIGATION IS CONFIRMED FOR ALLEGED PERFORATION OF THE INFERIOR VENA CAVA. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR ALLEGED FILTER TILT. FOR 4 MALFUNCTIONS, MATERIAL DEFORMATION WAS CODED ADDITIONALLY. OF THESE 4 MALFUNCTIONS, TWO INVESTIGATION CONFIRMED FOR FILTER LIMB PERFORATION OF THE IVC WALLS AND MATERIAL DEFORMATION. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND OTHER TWO INVESTIGATIONS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND MATERIAL DEFORMATION. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR FILTER TILT. FOR ONE MALFUNCTION, POSITIONING ISSUE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC AND POSITIONING ISSUE. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR FILTER TILT. FOR ONE MALFUNCTION, MIGRATION WAS CODED ADDITIONALLY, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT AND PERFORATION OF THE INFERIOR VENA CAVA (IVC). HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER MIGRATION. FOR TWO MALFUNCTIONS, DIFFICULT TO REMOVE WAS CODED ADDITIONALLY. OF THE TWO MALFUNCTIONS, ONE MALFUNCTION CONFIRMED FOR PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND FILTER TILT. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR RETRIEVAL DIFFICULTIES AND ANOTHER MALFUNCTION INCONCLUSIVE FOR THE ALLEGED FILTER TILT, PERFORATION AND UNABLE TO RETRIEVE. FOR REMAINING ONE MALFUNCTION, THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: GFTE3381, GFRK9360, GFRC0556, GFRE2952, GFTI2511, UNKNOWN), G3. H11: B5, H6 (RESULT, CONCLUSION). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE THIRTY REPORTED MALFUNCTIONS, 7 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS SERIOUS INJURY AND WERE REPORTED UNDER EMDRS 2020394-2020-06497, 2020394-2020-06505, 2020394-2021-80186, 2020394-2021-80183, 2020394-2021-80288, 2020394-2021-80301, AND EMDR CHILD REC 1748316. ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A DEATH AND WERE REPORTED UNDER EMDR 2020394-2019-04779. H10: OF THE REMAINING 22 MALFUNCTIONS, PRODUCT CATALOG NUMBER OF THREE MALFUNCTIONS UPDATED TO RF320J, TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO UNKNOWN FILTER, ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO RF400J (G2X FILTER) AND TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F (G2X FILTER). H10: THE LOT NUMBER WAS PROVIDED FOR EIGHT MALFUNCTIONS AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 21 MALFUNCTIONS AND 11 OF THE RECORDS INCLUDED IMAGES FOR REVIEW. THEREFORE, FOR EIGHT MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, FOR ONE MALFUNCTION THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FILTER TILT AND PERFORATION, FOR THREE MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND UNCONFIRMED FOR FILTER TILT, FOR TWO MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND INCONCLUSIVE FOR FILTER TILT, FOR TWO MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND UNCONFIRMED FOR FILTER TILT, ADDITIONALLY THESE WERE DETERMINED TO HAVE AND CONFIRMED FOR MATERIAL DEFORMATION(A0406), FOR TWO MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND INCONCLUSIVE FOR FILTER TILT, ADDITIONALLY THESE WERE DETERMINED TO HAVE AND CONFIRMED FOR MATERIAL DEFORMATION(A0406), FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND UNCONFIRMED FOR FILTER TILT, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR POSITIONING ISSUE(A1502), FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND FILTER TILT, ADDITIONALLY IT WAS DETERMINED TO HAVE AND INCONCLUSIVE FOR MIGRATION(A0104), FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND FILTER TILT, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR UNABLE TO REMOVE(A150207) AND FOR THE REMAINING ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION AND FILTER TILT, ADDITIONALLY IT WAS DETERMINED TO HAVE AND INCONCLUSIVE FOR UNABLE TO REMOVE(A150207). BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: GFTE3381, GFTI2511, GFRE2952, GFRK9360, GFRC0556, UNKNOWN), G3. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE THIRTY REPORTED MALFUNCTIONS, 7 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS SERIOUS INJURY AND WERE REPORTED UNDER EMDRS 2020394-2021-80186, 2020394-2020-0650, 2020394-2021-80183, 2020394-2020-06497, 2020394-2021-80301, 2020394-2021-80389 AND 2020394-2021-80288. ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A DEATH AND WERE REPORTED UNDER EMDR 2020394-2019-04779. H10: OF THE REMAINING 22 MALFUNCTIONS, PRODUCT CATALOG NUMBER OF THREE MALFUNCTIONS UPDATED TO RF320J, TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO UNKNOWN FILTER, ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO RF400J (G2X FILTER) AND TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F (G2X FILTER). H10: THE LOT NUMBER WAS PROVIDED FOR EIGHT MALFUNCTIONS AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 21 MALFUNCTIONS AND 13 OF THE RECORDS INCLUDED IMAGES FOR REVIEW. FOR EIGHT MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION. TWO MALFUNCTIONS ARE CONFIRMED FOR THE REPORTED PERFORATION AND INCONCLUSIVE FOR FILTER TILT. THREE MALFUNCTIONS WERE CONFIRMED FOR ALLEGED PERFORATION BUT UNCONFIRMED FOR TILT. MEDICAL RECORD WAS NOT PROVIDED FOR ONE OF THE TWENTY TWO MALFUNCTIONS, THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FILTER TILT AND PERFORATION. FOR TWO MALFUNCTIONS, THE INVESTIGATION IS UNCONFIRMED FOR FILTER TILT AND CONFIRMED FOR PERFORATION AND MATERIAL DEFORMATION, THEREFORE A0406 TRENDING DEVICE CODE WAS ADDED. TWO MALFUNCTIONS WERE CONFIRMED FOR PERFORATION AND MATERIAL DEFORMATION; HOWEVER, INCONCLUSIVE FOR TILT. FOR ONE MALFUNCTION, PERFORATION AND TILT ARE CONFIRMED BUT INCONCLUSIVE FOR MIGRATION. THE INVESTIGATION FOR ONE OF THE TWENTY TWO REPORTED MALFUNCTIONS WAS CONFIRMED FOR PERFORATION AND MIGRATION AND A10402 TRENDING DEVICE WAS ADDED TO THIS MALFUNCTION BUT UNCONFIRMED FOR TILT. ONE MALFUNCTION IS CONFIRMED FOR REPORTED PERFORATION AND POSITIONING PROBLEM, THEREFORE A1502 TRENDING DEVICE CODE WAS ADDED; BUT UNCONFIRMED FOR TILT. THE REMAINING MALFUNCTION IS CONFIRMED FOR THE ALLEGED PERFORATION, TILT AND RETRIEVAL DIFFICULTIES, THEREFORE A150207 TRENDING DEVICE CODE WAS ADDED. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: GFTE3381, GFTI2511, GFRE2952, GFRK9360, GFRC0556, UNKNOWN), G3. H11: B5. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE THIRTY REPORTED MALFUNCTIONS, 1 WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A DEATH, AND WERE REPORTED UNDER EMDR 2020394-2019-04779. H10: THE LOT NUMBER WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED FOR THREE OF THE MALFUNCTIONS; THE LOT NUMBER WAS NOT PROVIDED FOR THE REMAINING MALFUNCTIONS. OF THE REMAINING 29 MALFUNCTIONS, THE DEVICES WERE NOT RETURNED; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR EIGHT MALFUNCTIONS ALONG WITH IMAGES FOR FOUR MALFUNCTIONS. FOR FOUR OF THE MALFUNCTIONS THAT PROVIDED MEDICAL RECORDS, PERFORATION AND TILT WERE CONFIRMED. FOR ONE OF THE MALFUNCTIONS THAT PROVIDED MEDICAL RECORDS, PERFORATION CONFIRMED AND TILT WAS INCONCLUSIVE. FOR ONE OF THE MALFUNCTIONS THAT PROVIDED MEDICAL RECORDS, PERFORATION AND POSITIONING ISSUE CONFIRMED; HOWEVER, TILT UNCONFIRMED. FOR TWO OF THE MALFUNCTIONS THAT PROVIDED MEDICAL RECORDS, PERFORATION AND MATERIAL DEFORMATION CONFIRMED; HOWEVER, INCONCLUSIVE FOR TILT. ADDITIONALLY, FOR ONE MALFUNCTION THAT DID NOT PROVIDED MEDICAL RECORDS, THE DEVICE CODE 1528 - DIFFICULT TO REMOVE WAS ADDED. FOR THE REMAINING 21 MALFUNCTIONS, MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW, THEREFORE THE INVESTIGATIONS ARE INCONCLUSIVE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: UNKNOWN), G4. H11: B5, D4(CORPORATE LOT NO), G1, H6(RESULTS & CONCLUSION). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
OF THE 30 ORIGINALLY REPORTED MALFUNCTIONS, THE PRODUCT CATALOG OF ONE DEVICE WAS UPDATED TO UNKNOWN G2X. ADDITIONALLY, FOR ONE MALFUNCTION, DEVICE CODE 1528 - DIFFICULT TO REMOVE WAS ADDED. NONE OF THE DEVICES HAVE BEEN RETURNED FOR EVALUATION. OF THE 29 MALFUNCTIONS, TWO HAD MEDICAL RECORDS RETURNED, BUT NO IMAGES, THE OTHER 27 HAD NO MEDICAL RECORDS OR IMAGES RETURNED. FOR THE MALFUNCTION INVOLVING THE FORTY-TWO YEAR OLD MALE, MEDICAL RECORDS WERE PROVIDED FOR REVIEW. APPROXIMATELY TWELVE YEARS AND THREE MONTHS POST FILTER DEPLOYMENT, A CT OF THE ABDOMEN REVEALED THE SUPERIOR ASPECT OF THE FILTER WAS NOTED TO BE TILTED TO THE RIGHT OF MIDLINE AND THE TINES APPEARED TO EXTEND BEYOND THE MARGIN OF THE INFERIOR VENA CAVAL WALL. THEREFORE, THE INVESTIGATION CAN BE CONFIRMED FOR FILTER TILT AND PERFORATION OF THE IVC. ANOTHER DEVICE WAS CONFIRMED FOR PERFORATION OF THE IVC, BUT INCONCLUSIVE FOR TILT. THE INVESTIGATION REMAINING 27 DEVICES IS INCONCLUSIVE FOR BOTH PERFORATION AND TILT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE.
H10: OF THE THIRTY REPORTED MALFUNCTIONS, 1 WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A DEATH AND WERE REPORTED UNDER EMDR 2020394-2019-04779. H10: THE LOT NUMBER WAS PROVIDED FOR THREE MALFUNCTIONS, THEREFORE, A LOT HISTORY REVIEWS WERE PERFORMED. OF THE 29 MALFUNCTIONS, TWO MALFUNCTIONS HAD THE PRODUCT CATALOG NUMBER UPDATED TO RF320J AND ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO RF400J. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 11 MALFUNCTIONS. FIVE MALFUNCTIONS WERE CONFIRMED FOR THE ALLEGED FILTER PERFORATION AND TILT. TWO MALFUNCTIONS WERE CONFIRMED FOR FILTER PERFORATION AND INCONCLUSIVE FOR TILT. TWO MALFUNCTIONS ARE CONFIRMED FOR PERFORATION AND MATERIAL DEFORMATION BUT ARE INCONCLUSIVE FOR TILT. ONE MALFUNCTION IS CONFIRMED FOR PERFORATION AND TILT BUT IS INCONCLUSIVE FOR RETRIEVAL DIFFICULTY. THE FINAL MALFUNCTION WITH MEDICAL RECORDS IS CONFIRMED FOR PERFORATION AND POSITIONING ISSUE BUT UNCONFIRMED FOR TILT. 18 MALFUNCTIONS DID NOT RECIEVE MEDICAL RECORDS AND ARE INCONCLUSIVE FOR TILT AND PERFORATION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: UNKNOWN),
OF THE 30 ORIGINALLY REPORTED MALFUNCTIONS, ONE LOT NUMBER WAS UPDATED TO GFTG3592, THE PRODUCT CATALOG OF ONE DEVICE WAS UPDATED TO UNKNOWN G2X, ONE CATALOG NUMBER WAS UPDATED RF400J WITH LOT NUMBER GFTG2799, TWO CATALOG NUMBERS WERE UPDATED TO RF400F, AND ONE CATALOG NUMBER WAS UPDATED TO RF320J WITH LOT NUMBER GFSH2013. ADDITIONALLY, FOR ONE MALFUNCTION DEVICE CODE 1528 - DIFFICULT TO REMOVE WAS ADDED, AND FOR TWO MALFUNCTIONS, DEVICE CODE 2976 MATERIAL DEFORMATION WAS ADDED. NONE OF THE DEVICES HAVE BEEN RETURNED FOR EVALUATION. HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR SEVEN MALFUNCTIONS ALONG WITH IMAGES FOR FOUR MALFUNCTIONS. THE COMPANY IS INVESTIGATION THE ISSUE AT THIS TIME. THE DEVICES WERE LABELED FOR SINGLE USE. THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE THIRTY REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS SERIOUS INJURY AND WERE REPORTED UNDER EMDRS 2020394-2020-06497, 2020394-2020-06505 AND ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A DEATH AND WERE REPORTED UNDER EMDR 2020394-2019-04779. H10: OF THE REMAINING 27 MALFUNCTIONS, PRODUCT CATALOG NUMBER OF ONE MALFUNCTION UPDATED TO RF320J, ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO UNK G2X, TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO UNKNOWN FILTER, NINE MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO UNKNOWN G2, ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO RF400J (G2X FILTER) AND ONE MALFUNCTION HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F (G2X FILTER). H10: THE LOT NUMBER WAS PROVIDED FOR SIX MALFUNCTIONS, THEREFORE, A LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 17 MALFUNCTIONS AND TEN OF THE RECORDS INCLUDED IMAGES FOR REVIEW. SEVEN MALFUNCTIONS WERE CONFIRMED FOR THE ALLEGED FILTER PERFORATION AND TILT. NINE MALFUNCTIONS ARE INCONCLUSIVE FOR FILTER PERFORATION AND TILT. TWO MALFUNCTIONS CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT. FOR ONE MALFUNCTION, INVESTIGATION IS CONFIRMED FOR ALLEGED PERFORATION OF THE INFERIOR VENA CAVA. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR ALLEGED FILTER TILT. FOR 4 MALFUNCTIONS, MATERIAL DEFORMATION WAS CODED ADDITIONALLY. OF THESE 4 MALFUNCTIONS, TWO INVESTIGATION CONFIRMED FOR FILTER LIMB PERFORATION OF THE IVC WALLS AND MATERIAL DEFORMATION. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND OTHER TWO INVESTIGATIONS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND MATERIAL DEFORMATION. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR FILTER TILT. FOR ONE MALFUNCTION, POSITIONING ISSUE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC AND POSITIONING ISSUE. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR FILTER TILT. FOR ONE MALFUNCTION, MIGRATION WAS CODED ADDITIONALLY, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT AND PERFORATION OF THE INFERIOR VENA CAVA (IVC). HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER MIGRATION. FOR REMAINING TWO MALFUNCTIONS, DIFFICULT TO REMOVE WAS CODED ADDITIONALLY. OF THE TWO MALFUNCTIONS, ONE MALFUNCTION CONFIRMED FOR PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND FILTER TILT. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR RETRIEVAL DIFFICULTIES AND ANOTHER MALFUNCTION INCONCLUSIVE FOR THE ALLEGED FILTER TILT, PERFORATION AND UNABLE TO RETRIEVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NUMBER: GFTE3381, GFRK9360, GFRC0556, UNKNOWN), G4 H11: B5, D4(CORPORATE LOT NUMBER) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THIS REPORT SUMMARIZES 22 MALFUNCTIONS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND FILTER PERFORATION. ALL 22 MALFUNCTIONS REPORTED NO PATIENT INJURY. OF THE 22 MALFUNCTIONS, TEN PATIENTS WERE REPORTED AS MALE AND 11 WERE REPORTED AS FEMALE. EIGHT PATIENTS WEIGHED BETWEEN 186 AND 314 POUNDS. 21 PATIENTS WERE REPORTED TO BE IN THE RANGE OF 33 TO 75 YEARS OLD. ALL OTHER PATIENT INFORMATION WAS NOT REPORTED.
THIS REPORT SUMMARIZES 22 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED FILTER TILT AND PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL 22 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 22 PATIENTS, 10 WERE MALE AND 11 WERE FEMALE, 21 PATIENTS AGE RANGED BETWEEN 33-75 YEARS AND 8 PATIENT WEIGHS IN THE RANGE BETWEEN 186 - 314 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 22 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED FILTER TILT AND PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL 22 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 22 PATIENTS, 10 WERE MALE AND 11 WERE FEMALE, 21 PATIENTS AGE RANGED BETWEEN 33-75 YEARS AND 9 PATIENT WEIGHS IN THE RANGE BETWEEN 178 - 314 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY NINE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F FILTER ALLEGEDLY EXPERIENCED MALPOSITIONING AND PATIENT-DEVICE INTERACTION PROBLEMS . ALL TWENTY NINE MALFUNCTIONS INVOLVED PATIENT CONTACT WITH NO KNOW IMPACT TO THE PATIENT. OF THE TWENTY NINE PATIENTS, THREE WERE FEMALE AND FIVE WERE MALE RANGING FROM 33 TO 67 YEARS OF AGE. FOUR PATIENT'S WEIGHTS RANGED FROM 81 - 142 KGS. THE PATIENT AGE, WEIGHT, AND GENDER FOR THE REMAINING PATIENTS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY-NINE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F FILTER ALLEGEDLY EXPERIENCED MALPOSITIONING AND PATIENT-DEVICE INTERACTION PROBLEMS. ALL TWENTY-NINE EVENTS INVOLVED PATIENT CONTACT. THE STATUS OF THE PATIENT FOR EACH EVENT IS UNKNOWN. ONE PATIENT INVOLVED WAS A FORTY-THREE YEAR-OLD FEMALE, OF UNKNOWN WEIGHT. ANOTHER PATIENT INVOLVED WAS A FORTY-TWO YEAR-OLD MALE, OF UNKNOWN WEIGHT. THE PATIENT AGE, WEIGHT, AND GENDER FOR THE REMAINING TWENTY-SEVEN EVENTS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 29 MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND FILTER PERFORATION. ALL 29 MALFUNCTIONS REPORTED NO PATIENT INJURY. OF THE 29 MALFUNCTIONS, FIVE PATIENTS WERE REPORTED AS MALE AND SIX WERE REPORTED AS FEMALE. FIVE PATIENTS WEIGHED BETWEEN 178 AND 314LBS. 11 PATIENTS WERE REPORTED TO BE IN THE RANGE OF 33 TO 75 YEARS OLD. ALL OTHER PATIENT INFORMATION WAS NOT REPORTED.
THIS REPORT SUMMARIZES THIRTY MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F FILTER ALLEGEDLY EXPERIENCED MALPOSITIONING AND PATIENT-DEVICE INTERACTION PROBLEMS. ALL THIRTY MALFUNCTIONS INVOLVED PATIENT CONTACT WITH NO KNOW IMPACT TO THE PATIENT. OF THE THIRTY PATIENTS, THREE WERE FEMALE AND FOUR WERE MALE RANGING FROM 33 TO 67 YEARS OF AGE AND BETWEEN WEIGHTS OF 81 KG AND 314 LB. THE PATIENT AGE, WEIGHT, AND GENDER FOR THE REMAINING PATIENTS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 27 MALFUNCTIONS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND FILTER PERFORATION. ALL 27 MALFUNCTIONS REPORTED NO PATIENT INJURY. OF THE 27 MALFUNCTIONS, NINE PATIENTS WERE REPORTED AS MALE AND EIGHT WERE REPORTED AS FEMALE. SIX PATIENTS WEIGHED BETWEEN 178 AND 314 POUNDS. 17 PATIENTS WERE REPORTED TO BE IN THE RANGE OF 33 TO 75 YEARS OLD. ALL OTHER PATIENT INFORMATION WAS NOT REPORTED.
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, FOR ALL THIRTY EVENTS; MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR THE EVENT INVOLVING A (B)(6) FEMALE. APPROXIMATELY ELEVEN YEARS POST FILTER DEPLOYMENT, A CT OF THE ABDOMEN AND PELVIS INDICATED CAVAL PERFORATION OF THE IVC, ONE PRONG PERFORATING THE AORTA, AND A SEVEN DEGREE FILTER TILT LEFT TO THE RIGHT. THEREFORE, THE INVESTIGATION CAN BE CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, BASED ON THE PROVIDED MEDICAL RECORDS, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AS THE TILT IS LESS THAN 15 DEGREES. FOR THE OTHER TWENTY-NINE EVENTS, THE INVESTIGATION IS INCONCLUSIVE FOR THE MALPOSITIONING AND DEVICE-PATIENT INTERACTION PROBLEM AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.
THIS REPORT SUMMARIZES THIRTY MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F FILTER ALLEGEDLY EXPERIENCED MALPOSITIONING AND PATIENT-DEVICE INTERACTION PROBLEMS . ALL THIRTY EVENTS INVOLVED PATIENT CONTACT . THE STATUS OF THE PATIENT FOR EACH EVENT IS UNKNOWN. ONE PATIENT INVOLVED WAS A (B)(6) FEMALE, OF UNKNOWN WEIGHT. ANOTHER PATIENT INVOLVED WAS A (B)(6) MALE, OF UNKNOWN WEIGHT. THE PATIENT AGE, WEIGHT, AND GENDER FOR THE REMAINING TWENTY-EIGHT EVENTS WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311054 | G2 FILTER | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFTG3592, GFTG2799, GFPH2838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |