G2 VENA CAVA FILTER
Report
- Report Number
- 2020394-2019-00385
- Event Type
- Malfunction
- Date Received
- April 16, 2019
- Report Date
- July 14, 2021
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
H10: OF THE 29 REPORTED MALFUNCTIONS, SIX WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2021-80244, 2020394-2020-06481, 2020394-2021-80226, 2020394-2021-80254, 2020394-2019-03268 AND 2020394-2020-06511, AND ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A MALFUNCTION, AND WERE REPORTED UNDER EMDR 2020394-2019-03889. H10: OF THE 22 REMAINING MALFUNCTIONS, TWO DEVICES WERE UPDATED TO RF320J, ONE DEVICE WAS UPDATED TO RF400F (G2 EXPRESS FILTER), AND ANOTHER DEVICE WAS UPDATE TO RF400F (G2X FILTER). H10: 14 OF THE 22 MALFUNCTIONS PROVIDED A LOT NUMBER AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 18 MALFUNCTIONS, 9 OF WHICH INCLUDED IMAGES. FOR 12 MALFUNCTIONS, THE INVESTIGATIONS ARE CONFIRMED FOR PERFORATION. FOR SEVEN MALFUNCTIONS, THE INVESTIGATIONS ARE INCONCLUSIVE FOR PERFORATION. FOR ONE MALFUNCTION, DIFFICULT TO REMOVE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC AND RETRIEVAL DIFFICULTIES. FOR ONE MALFUNCTION, MIGRATION WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA AND FILTER MIGRATION. FOR REMAINING ONE MALFUNCTION, MALPOSITION OF DEVICE WAS ADDED ADDITIONALLY AND THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NUMBER: GFPG4066, GFRL1938, GFUE4484, GFQF4280, GFSE2706, GFQA2989, GFSI2335, GFTA3054, GFSG3648, GFTB3662, GFSK1772, UNKNOWN), G3. H11: B5, 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.
H10: OF THE 29 REPORTED MALFUNCTIONS, SEVEN WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2021-80244, 2020394-2020-06481, 2020394-2021-80226, 2020394-2021-80254, 2020394-2019-03268 AND 2020394-2020-06511, 2020394-2021-80408, AND ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A MALFUNCTION, AND WERE REPORTED UNDER EMDR 2020394-2019-03889. H10: OF THE 21 REMAINING MALFUNCTIONS, THREE DEVICES WERE UPDATED TO RF320J, ONE DEVICE WAS UPDATED TO RF400F (G2 EXPRESS FILTER), AND ANOTHER DEVICE WAS UPDATE TO RF400F (G2X FILTER). H10: 16 OF THE 21 MALFUNCTIONS PROVIDED A LOT NUMBER AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 20 MALFUNCTIONS, 9 OF WHICH INCLUDED IMAGES. FOR 14 MALFUNCTIONS, THE INVESTIGATIONS ARE CONFIRMED FOR PERFORATION. FOR FOUR MALFUNCTIONS, THE INVESTIGATIONS ARE INCONCLUSIVE FOR PERFORATION. FOR ONE MALFUNCTION, DIFFICULT TO REMOVE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC AND RETRIEVAL DIFFICULTIES. FOR ONE MALFUNCTION, MIGRATION WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA AND FILTER MIGRATION. FOR REMAINING ONE MALFUNCTION, MALPOSITION OF DEVICE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA AND INCONCLUSIVE FOR TILT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NUMBER: GFPG4066, GFRL1938, GFUE4484, GFQF4280, GFSE2706, GFQA2989, GFSI2335, GFTA3054, GFSG3648, GFTB3662, GFSK1772, GFSG3611, GFPK1238, UNKNOWN), G3 H11: B5, 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.
H10: FIVE OF THE TWENTY-NINE EVENTS PROVIDED A LOT NUMBER AND A MANUFACTURING REVIEW WAS PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR SEVEN OF THE MALFUNCTIONS, THREE OF WHICH INCLUDED IMAGES. OF THE SEVEN MEDICAL RECORDS AND/OR IMAGES, FOUR CONFIRMED A PATIENT-DEVICE INTERACTION PROBLEM, ONE CONFIRMED A PATIENT-DEVICE INTERACTION PROBLEM AND DIFFICULTY TO REMOVE (1528), AND ONE CONFIRMED A PATIENT DEVICE INTERACTION PROBLEM AND MALPOSITION OF THE DEVICE (2616). ONE MEDICAL RECORD COULD NOT DEFINITIVELY CONFIRM THE ALLEGATION AND IS THEREFORE INCONCLUSIVE. OF THE TWENTY-NINE MALFUNCTIONS, TWENTY-THREE ARE INCONCLUSIVE AS NO DEVICE, MEDICAL RECORD, IMAGES, OR OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. ONE MALFUNCTION HAD ADDITIONAL INFORMATION PROVIDED AND THE DEVICE CODES WERE UPDATED TO INCLUDE MALPOSITION (2616). BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: OF THE 29 DEVICES, THE PRODUCT CATALOG NUMBER OF 2 DEVICE WAS UPDATED TO RF400F. H10: OF THE 29 REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE, AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-03268 AND 2020394-2019-03889.
H10: OF THE 29 REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE, AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-03268 AND 2020394-2019-03889. H10: OF THE 27 REMAINING MALFUNCTIONS, THE PRODUCT CATALOG NUMBER OF 2 DEVICE WAS UPDATED TO RF400F. H10: SIX OF THE 27 MALFUNCTIONS PROVIDED A LOT NUMBER AND A MANUFACTURING REVIEW WAS PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR NINE OF THE MALFUNCTIONS, THREE OF WHICH INCLUDED IMAGES. OF THE NINE MEDICAL RECORDS AND/OR IMAGES, FIVE CONFIRMED A PATIENT-DEVICE INTERACTION PROBLEM, ONE CONFIRMED A PATIENT-DEVICE INTERACTION PROBLEM AND DIFFICULTY TO REMOVE, AND ONE CONFIRMED A PATIENT DEVICE INTERACTION PROBLEM AND MIGRATION. TWO MEDICAL RECORDS COULD NOT DEFINITIVELY CONFIRM THE ALLEGATION AND ARE THEREFORE INCONCLUSIVE. THE REMAINING 18 MALFUNCTIONS ARE INCONCLUSIVE AS NO DEVICE, MEDICAL RECORD, IMAGES, OR OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. ONE MALFUNCTION HAD ADDITIONAL INFORMATION PROVIDED AND THE DEVICE CODES WERE UPDATED TO INCLUDE MALPOSITION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NUMBER: GFQI3976, GFSK1772, UNKNOWN), G4. H11: B5, G1, H2, H6 (METHOD, 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.
H10: THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED FOR TWENTY-FOUR OF THE TWENTY-NINE REPORTED EVENTS; THEREFORE, A MANUFACTURING REVIEW COULD NOT BE PERFORMED FOR TWENTY-FOUR MALFUNCTIONS. FIVE OF THE TWENTY-NINE EVENTS PROVIDED A LOT NUMBER AND A MANUFACTURING REVIEW WAS PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS AND/OR IMAGES WERE PROVIDED FOR SEVEN OF THE MALFUNCTIONS. OF THE SEVEN MEDICAL RECORDS AND/OR IMAGES, THREE CONFIRMED A PATIENT-DEVICE INTERACTION PROBLEM, ONE CONFIRMED A PATIENT-DEVICE INTERACTION PROBLEM AND DIFFICULTY TO REMOVE (1528), AND ONE CONFIRMED A PATIENT DEVICE INTERACTION PROBLEM AND MALPOSITION OF THE DEVICE (2616). TWO MEDICAL RECORDS COULD NOT DEFINITIVELY CONFIRM THE ALLEGATION AND ARE THEREFORE INCONCLUSIVE. OF THE TWENTY-NINE MALFUNCTIONS, TWENTY-FIVE ARE INCONCLUSIVE AS NO DEVICE, MEDICAL RECORD, IMAGES, OR OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. ONE MALFUNCTION HAD ADDITIONAL INFORMATION PROVIDED AND THE DEVICE CODES WERE UPDATED TO INCLUDE MALPOSITION (2616). BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: OF THE 29 DEVICES, THE PRODUCT CATALOG NUMBER OF 2 DEVICE WAS UPDATED TO RF400F. H10: OF THE 29 REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE, AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-03268 AND 2020394-2019-03889. H10: D4 (CORPORATE LOT NUMBER: GFQI3976, GFSK1772, UNKNOWN). H11: B5, 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.
H10: OF THE 29 REPORTED MALFUNCTIONS, 3 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE, AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-03268, 2020394-2020-06481, 2020394-2020-06511 AND ONE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE, AS A MALFUNCTION, AND WERE REPORTED UNDER EMDR 2020394-2019-03889. H10: OF THE 25 REMAINING MALFUNCTIONS, THE PRODUCT CATALOG NUMBER OF 11 DEVICES WERE UPDATED TO UNKNOWN G2, ONE DEVICE WAS UPDATED TO RF400F (G2 EXPRESS FILTER) AND ANOTHER DEVICE WAS UPDATE TO RF400F (G2X FILTER). H10: 10 OF THE 25 MALFUNCTIONS PROVIDED A LOT NUMBER AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 14 MALFUNCTIONS, 9 OF WHICH INCLUDED IMAGES. TEN INVESTIGATIONS CONFIRMED FOR PATIENT-DEVICE INTERACTION PROBLEM. 12 MALFUNCTIONS ARE INCONCLUSIVE FOR PERFORATION. FOR ONE MALFUNCTION, MALPOSITION WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FILTER TILT AND PERFORATION OF THE IVC. FOR ONE MALFUNCTION, DIFFICULT TO REMOVE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC AND RETRIEVAL DIFFICULTIES. FOR ONE MALFUNCTION, MIGRATION WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA AND FILTER MIGRATION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NUMBER: GFPG4066, GFRL1938, GFUE4484, GFQF4280, GFSE2706, GFQA2989, GFRE4513, UNKNOWN). 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.
THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED FOR TWENTY-FOUR OF THE TWENTY-NINE REPORTED EVENTS; THEREFORE, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. FIVE OF THE TWENTY-NINE EVENTS PROVIDED A LOT NUMBER AND A MANUFACTURING REVIEW WILL BE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS AND IMAGES WERE PROVIDED FOR FIVE OF THE MALFUNCTIONS. THE COMPANY IS CURRENTLY INVESTIGATING THE ISSUE AT THIS TIME. OF THE 29 DEVICES, THE PRODUCT CATALOG NUMBER OF 2 DEVICE WAS UPDATED TO RF400F. OF THE 10 REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE, AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-03268 AND 2020394-2019-03889. (CORPORATE LOT NUMBER: GFQI3976, GFSK1772, UNKNOWN).
THIS REPORT SUMMARIZES 22 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATIONS INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL 22 MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. OF THE 22 PATIENTS, 18 PATIENTS' AGES WERE REPORTED TO BE BETWEEN 17-80 YEARS AND FOUR PATIENTS¿ WEIGHT WERE REPORTED TO BE BETWEEN 198-282 LBS, EIGHT PATIENTS WERE REPORTED AS MALE, AND 10 PATIENTS WERE REPORTED AS FEMALE. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 21 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATIONS INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL 21 MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. OF THE 21 PATIENTS, 20 PATIENTS' AGES WERE REPORTED TO BE BETWEEN 17-80 YEARS AND SIX PATIENTS¿ WEIGHT WERE REPORTED TO BE BETWEEN 155-282 LBS, NINE PATIENTS WERE REPORTED AS MALE, AND 11 PATIENTS WERE REPORTED AS FEMALE. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY-NINE MALFUNCTIONS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWENTY-NINE EVENTS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. SEVEN PATIENTS' INFORMATION WAS PROVIDED AND THE AGE RANGE IS 17-80 YEARS. THREE PATIENTS WERE MALE AND FIVE WERE FEMALE. THE WEIGHT OF TWO PATIENTS WAS 192 AND 223 POUNDS. THE REMAINING PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY SEVEN MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATIONS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWENTY NINE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. NINE PATIENTS' INFORMATIONS WAS PROVIDED AND THE AGE RANGE WAS 17-80 YEARS. SIX PATIENTS WERE MALE AND THREE WERE FEMALE. THE REMAINING PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY-NINE MALFUNCTIONS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWENTY-NINE EVENTS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. SEVEN PATIENTS' INFORMATION WAS PROVIDED AND THE AGE RANGE IS 17-60 YEARS. THREE PATIENTS WERE MALE AND FOUR WERE FEMALE. THE WEIGHT OF TWO PATIENTS WAS 192 AND 223 POUNDS. THE REMAINING PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATIONS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWENTY FIVE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. 14 PATIENTS AGES RANGED FROM 17-80 YEARS. SEVEN PATIENTS WERE MALE AND SEVEN WERE FEMALE. ONE PATIENT WEIGHT WAS 95 KGS, AND TWO OTHER PATIENT'S WEIGHT 165 AND 223LBS. THE REMAINING PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY-NINE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWENTY-NINE EVENTS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. FOUR PATIENTS' INFORMATION WAS PROVIDED AND THE AGE RANGE IS 17-49 YEARS. THREE ARE MALE AND 1 IS FEMALE. WEIGHT WAS NOT PROVIDED. THE REMAINING PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED FOR TWENTY-EIGHT OF THE TWENTY-NINE REPORTED EVENTS; THEREFORE, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. ONE OF THE TWENTY-NINE EVENTS PROVIDED A LOT NUMBER AND A MANUFACTURING REVIEW WILL BE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE PATIENT DEVICE 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 TWENTY-NINE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL TWENTY-NINE EVENTS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR ANY OF THE PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311363 | G2 VENA CAVA FILTER | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFQG3607, GFQI3976, GFRF3699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |