G2 FILTER
Report
- Report Number
- 2020394-2019-01958
- Event Type
- Malfunction
- Date Received
- July 25, 2019
- Report Date
- July 26, 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
OF THE 32 REPORTED MALFUNCTIONS, 8 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY AND WERE REPORTED UNDER EMDR'S 2020394-2021-80245, 2020394-2020-05962, 2020394-2020-05948, 2020394-2019-03478, 2020394-2020-06437, 2020394-2020-06434, 2020394-2020-06519 AND 2020394-2019-03641. THE LOT NUMBER WAS PROVIDED FOR 11 OUT OF 24 MALFUNCTIONS, THEREFORE, A LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 23 MALFUNCTIONS. IMAGES WERE PROVIDED AND REVIEWED FOR 4 MALFUNCTIONS. FOR 11 MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT AND PERFORATION OF THE IVC. FOR 5 MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR ALLEGED FILTER TILT. FOR 4 MALFUNCTIONS, THE INVESTIGATION IS INCONCLUSIVE FOR PERFORATION OF THE IVC AND FILTER TILT. FOR ONE MALFUNCTION, MATERIAL DEFORMATION WAS CODED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED ALLEGED FILTER TILT, MATERIAL DEFORMATION AND PERFORATION OF THE INFERIOR VENA CAVA (IVC). FOR ONE MALFUNCTION, DETACHMENT AND DIFFICULT TO REMOVE CODES WERE ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR THE FILTER TILT, PERFORATION OF THE INFERIOR VENA CAVA (IVC), FILTER LIMB DETACHMENT AND RETRIEVAL DIFFICULTIES. FOR ONE MALFUNCTION, MIGRATION CODE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS IDENTIFIED FOR FILER TILT, PERFORATION OF INFERIOR VENA CAVA AND MIGRATION. FOR THE REMAINING ONE MALFUNCTION, OCCLUSION CODE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR FILER TILT, PERFORATION OF INFERIOR VENA CAVA AND OCCLUSION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. (CORPORATE LOT NO: GFSG3608, GFVG2310, GFSG3587, GFTK2859, GFTH3820, GFTB2060, GFQL0330, GFSH3624, UNKNOWN) 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 32 REPORTED MALFUNCTIONS, 9 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY AND WERE REPORTED UNDER EMDR'S 2020394-2021-80245, 2020394-2020-05962, 2020394-2020-05948, 2020394-2019-03478, 2020394-2020-06437, 2020394-2021-80439, 2020394-2020-06434, 2020394-2019-03641 AND 2020394-2020-06519. H10: OF THE REPORTED 23 MALFUNCTIONS, LOT NUMBERS WERE PROVIDED FOR 11 MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE PRODUCT CATALOG NUMBER FOR ONE FILE WAS UPDATES AS UNKNOWN G2. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION; HOWEVER; MEDICAL RECORDS WERE RECEIVED FOR ALL 23 MALFUNCTIONS AND IMAGES WAS PROVIDED FOR FIVE MALFUNCTIONS. THEREFORE, FOR 11 MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, FOR FIVE MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR PERFORATION AND INCONCLUSIVE THE FILTER TILT, FOR THREE MALFUNCTIONS THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FILTER TILT AND PERFORATION, FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR MIGRATION(A0104), FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR MATERIAL DEFORMATION(A0406), FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR DETACHMENT(A0501) AND RETRIEVAL DIFFICULTIES, AND FOR REMAINING ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR OCCLUSION(A1409). 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 NO: GFSG3608, GFVG2310, GFSG3587, GFTK2859, GFTH3820, GFTB2060, GFQL0330, GFSH3624, 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 32 REPORTED MALFUNCTIONS, 10 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY AND WERE REPORTED UNDER EMDR'S 2020394-2022-90160, 2020394-2021-80245, 2020394-2020-05962, 2020394-2020-05948, 2020394-2019-03478, 2020394-2020-06437, 2020394-2021-80439, 2020394-2020-06434, 2020394-2019-03641 AND 2020394-2020-06519. H10: OF THE REPORTED 22 MALFUNCTIONS, LOT NUMBERS WERE PROVIDED FOR 10 MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE PRODUCT CATALOG NUMBER FOR ONE FILE WAS UPDATES AS UNKNOWN G2. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION; HOWEVER; MEDICAL RECORDS WERE RECEIVED FOR ALL 22 MALFUNCTIONS AND IMAGES WAS PROVIDED FOR 4 MALFUNCTIONS. THEREFORE, FOR 11 MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, FOR FIVE MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR PERFORATION AND INCONCLUSIVE THE FILTER TILT, FOR THREE MALFUNCTIONS THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FILTER TILT AND PERFORATION, FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR MATERIAL DEFORMATION(A0406), FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR DETACHMENT(A0501) AND RETRIEVAL DIFFICULTIES(A150207), AND FOR REMAINING ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND PERFORATION, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR OCCLUSION(A1409). 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 NO: GFVG2310, GFSG3587, GFTK2859, GFTH3820, GFTB2060, GFQL0330, GFSH3624, UNKNOWN), G3. H11: B5, D4(CORPORATE LOT NO). 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 32 REPORTED MALFUNCTIONS, 4 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY AND WERE REPORTED UNDER EMDR'S 2020394-2020-05948, 2020394-2019-03478 AND 2020394-2019-03641; HOWEVER, ONE MALFUNCTION IS STILL NOT REPORTED. H10: THE LOT NUMBER WAS PROVIDED FOR 11 OUT OF 28 MALFUNCTIONS, THEREFORE, A LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 20 MALFUNCTIONS. IMAGES WERE PROVIDED AND REVIEWED FOR 2 OUT OF 28 MALFUNCTIONS. FOR 8 OF THE 28 REPORTED MALFUNCTIONS, MEDICAL RECORDS WERE NOT PROVIDED, AND THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION AND TILT AS NO OBJECTIVE EVIDENCE WAS PROVIDED. THE INVESTIGATION FOR THE REPORTED 9 MALFUNCTIONS WERE CONFIRMED FOR THE PERFORATION AND TILT. 5 MALFUNCTIONS WERE CONFIRMED FOR PERFORATION BUT INCONCLUSIVE FOR TILT. THE INVESTIGATION FOR THE THREE REPORTED MALFUNCTIONS WERE INCONCLUSIVE FOR BOTH ALLEGED PERFORATION AND TILT. PERFORATION, TILT, AND MATERIAL DEFORMATION WERE CONFIRMED FOR ONE MALFUNCTION. FOR 1 OF THE 28 MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION, TILT, DETACHMENT, AND RETRIEVAL DIFFICULTIES. THE REMAINING MALFUNCTION IS CONFIRMED FOR PERFORATION, TILT, AND OCCLUSION OF THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NUMBER: GFRC0082,GFSG3608,GFVG2310,GFSG3587,GFTK2859,GFTH3820,GFTB2060,GFSH3624,UNKNOWN),G4. 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 32 REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDR'S 2020394-2019-03641. H10: OF THE THIRTY-TWO (32) REPORTED DEVICES, NONE WERE RETURNED FOR EVALUATION, MEDICAL RECORDS WERE PROVIDED FOR FIFTEEN DEVICES, AND IMAGES WERE PROVIDED FOR TWO. THE INVESTIGATION OF EIGHT OF THE REPORTED DEVICES CONFIRMED THAT THE DEVICE TILTED AND PERFORATED THE IVC. THE INVESTIGATION CONFIRMED PERFORATION OF THE IVC, BUT WAS INCONCLUSIVE FOR TILT IN FIVE (5) OF THE DEVICES. THE INVESTIGATION OF THE REMAINING NINETEEN (19) DEVICES WAS INCONCLUSIVE FOR BOTH TILT AND PERFORATION OF THE IVC. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. 2020394-2019-01958-2 (CORPORATE LOT NUMBER: GFTK2859, GFPI3143, GFRE0615, GFRC0082, GFTB2060, GFQF2558, GFRC2690, GFPH2338, GFSG3608, GFSH3624), 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 32 REPORTED MALFUNCTIONS, 2 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDR'S 2020394-2019-03478 AND 2020394-2019-03641. OF THE THIRTY-TWO (32) REPORTED DEVICES, NONE WERE RETURNED FOR EVALUATION, MEDICAL RECORDS WERE PROVIDED FOR THIRTEEN (13) DEVICES, AND IMAGES WERE PROVIDED FOR ONE. THE INVESTIGATION OF SIX (6) OF THE REPORTED DEVICES CONFIRMED THAT THE DEVICE TILTED AND PERFORATED THE IVC. THE INVESTIGATION CONFIRMED PERFORATION OF THE IVC, BUT WAS INCONCLUSIVE FOR TILT IN FIVE (5) OF THE DEVICES. THE INVESTIGATION OF THE REMAINING NINETEEN (19) DEVICES WAS INCONCLUSIVE FOR BOTH TILT AND PERFORATION OF THE IVC. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NUMBER: GFTK2859, GFPI3143, GFRE0615, GFRC0082, GFTB2060, GFQF2558, GFRC2690, GFPH2338, GFSG3608, GFSH3624), G4. H11: G1.
H10: OF THE 32 REPORTED MALFUNCTIONS, 7 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY AND WERE REPORTED UNDER EMDR'S 2020394-2020-05962, 2020394-2020-05948, 2020394-2019-03478, 2020394-2020-06437, 2020394-2020-06434, 2020394-2020-06519 AND 2020394-2019-03641. H10: THE LOT NUMBER WAS PROVIDED FOR 12 OUT OF 25 MALFUNCTIONS, THEREFORE, A LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 22 MALFUNCTIONS. IMAGES WERE PROVIDED AND REVIEWED FOR 4 MALFUNCTIONS. FOR 11 MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT AND PERFORATION OF THE IVC. FOR 5 MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR ALLEGED FILTER TILT. FOR 6 MALFUNCTIONS, THE INVESTIGATION IS INCONCLUSIVE FOR PERFORATION OF THE IVC AND FILTER TILT. FOR ONE MALFUNCTION, MATERIAL DEFORMATION WAS CODED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED ALLEGED FILTER TILT, MATERIAL DEFORMATION AND PERFORATION OF THE INFERIOR VENA CAVA (IVC). FOR ONE MALFUNCTION, DETACHMENT AND DIFFICULT TO REMOVE CODES WERE ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR THE FILTER TILT, PERFORATION OF THE INFERIOR VENA CAVA (IVC), FILTER LIMB DETACHMENT AND RETRIEVAL DIFFICULTIES. FOR THE REMAINING ONE MALFUNCTION, OCCLUSION CODE WAS ADDED ADDITIONALLY AND THE INVESTIGATION IS CONFIRMED FOR FILER TILT, PERFORATION OF INFERIOR VENA CAVA AND OCCLUSION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NO: GFRC0082, GFSG3608, GFVG2310, GFSG3587, GFTK2859, GFTH3820, GFTB2060, GFQL0330, GFSH3624, UNKNOWN), G4 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.
THIS REPORT SUMMARIZES TWENTY FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED A MALPOSITION OF DEVICE AND PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THE TWENTY FOUR MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. OF THE 24 REPORTED PATIENTS, 12 WERE FEMALE AND 11 WERE MALE. 20 PATIENTS AGES RANGED FROM 32 TO 87 YEARS OLD. SEVEN PATIENTS WEIGHT RANGED FROM 64 TO 123 KGS. THE REMAINING PATIENTS AGE, GENDER AND WEIGHT WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 23 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 23 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 23 PATIENTS, 11 WERE MALE AND 12 WERE FEMALE, 20 PATIENTS AGE RANGED BETWEEN 32-87 YEARS AND 7 PATIENTS WEIGHS IN THE RANGE BETWEEN 64-123 KGS. 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, 11 WERE MALE AND 11 WERE FEMALE, 19 PATIENTS AGE RANGED BETWEEN 32-87 YEARS AND 7 PATIENTS WEIGHS IN THE RANGE BETWEEN 64-123 KGS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES TWENTY EIGHT MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED A MALPOSITION OF DEVICE AND PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THE TWENTY EIGHT MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. OF THE 28 REPORTED PATIENTS, NINE WERE FEMALE AND TEN MALE PATIENTS AGES RANGED FROM 44 TO 75 YEARS OLD. SEVEN FEMALE PATIENTS AGES RANGED FROM 44 TO 87 YEARS OLD. FOUR FEMALE PATIENTS WEIGHT RANGED FROM 64 TO 103 KGS AND THREE MALE PATIENTS AGE RANGED FROM 82 TO 123 KGS. THE REMAINING PATIENTS AGE, GENDER AND WEIGHT WERE NOT PROVIDED.
THIS REPORT SUMMARIZES THIRTY-TWO (32) MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTERS ALLEGEDLY EXPERIENCED A MALPOSITION OF DEVICE AND A PATIENT DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE ALLEGED MALFUNCTIONS EACH INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. OF THE (32) REPORTED PATIENTS, (19) PATIENTS AGES, WEIGHTS, AND GENDERS WERE NOT PROVIDED. EIGHT PATIENTS WERE REPORTED TO BE MALE WITH REPORTED AGES RANGING FROM 44 TO 75-YEARS-OLD AND THREE REPORTED WEIGHTS IN THE RANGE OF 82KG - 123 KG. SEVEN PATIENTS WERE REPORTED TO BE FEMALE WITH REPORTED AGES RANGING FROM 51 TO 87-YEARS-OLD AND FOUR REPORTED WEIGHTS OF 64 - 103 KG.
THIS REPORT SUMMARIZES THIRTY-TWO (32) MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTERS ALLEGEDLY EXPERIENCED A MALPOSITION OF DEVICE AND A PATIENT DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE ALLEGED MALFUNCTIONS EACH INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. OF THE (32) REPORTED PATIENTS, (19) PATIENTS AGES, WEIGHTS, AND GENDERS WERE NOT PROVIDED. SEVEN PATIENTS WERE REPORTED TO BE MALE WITH REPORTED AGES RANGING FROM 44 TO 75-YEARS-OLD AND THREE REPORTED WEIGHTS ON 82KG, 271LB, AND 219LB. SIX PATIENTS WERE REPORTED TO BE FEMALE WITH REPORTED AGES RANGING FROM 51 TO 87-YEARS-OLD AND THREE REPORTED WEIGHTS OF 218LB, 64KG, AND 103KG.
THIS REPORT SUMMARIZES TWENTY FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED A MALPOSITION OF DEVICE AND PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THE TWENTY FIVE MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. OF THE 25 REPORTED PATIENTS, 11 WERE FEMALE AND 11 WERE MALE. 19 PATIENTS AGES RANGED FROM 32 TO 87 YEARS OLD. SEVEN PATIENTS WEIGHT RANGED FROM 64 TO 123 KGS. THE REMAINING PATIENTS AGE, GENDER AND WEIGHT WERE NOT PROVIDED.
OF THE THIRTY-TWO (32) REPORTED DEVICES, NONE WERE RETURNED FOR EVALUATION, MEDICAL RECORDS WERE PROVIDED FOR THIRTEEN (13) DEVICES, AND IMAGES WERE PROVIDED FOR ONE. THE INVESTIGATION OF SEVEN (7) OF THE REPORTED DEVICES CONFIRMED THAT THE DEVICE TILTED AND PERFORATED THE IVC. THE INVESTIGATION CONFIRMED PERFORATION OF THE IVC, BUT WAS INCONCLUSIVE FOR TILT IN FOUR (4) OF THE DEVICES. THE INVESTIGATION OF THE REMAINING SIXTEEN (21) DEVICES WAS INCONCLUSIVE FOR BOTH TILT AND PERFORATION OF THE IVC. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. (CORPORATE LOT NUMBER: GFTK2859, GFPI3143, GFRE0615, GFRC0082, GFTB2060, GFQF2558, GFRC2690, GFPH2338, GFSG3608).
THIS REPORT SUMMARIZES THIRTY-TWO (32) MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTERS ALLEGEDLY EXPERIENCED A MALPOSITION OF DEVICE AND A PATIENT DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE ALLEGED MALFUNCTIONS EACH INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. OF THE (32) REPORTED PATIENTS, (19) PATIENTS AGES, WEIGHTS, AND GENDERS WERE NOT PROVIDED. SEVEN PATIENTS WERE REPORTED TO BE MALE WITH REPORTED AGES RANGING FROM 44 TO 75-YEARS-OLD AND THREE REPORTED WEIGHTS ON 82KG, 271LB, AND 219LB. SIX PATIENTS WERE REPORTED TO BE FEMALE WITH REPORTED AGES RANGING FROM 51 TO 87-YEARS-OLD AND THREE REPORTED WEIGHTS OF 218LB, 64KG, AND 103KG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619730 | G2 FILTER | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFPI3143, GFRC0082, GFSG3608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |