DENALI FEMORAL SYSTEM
Report
- Report Number
- 2020394-2023-01212
- Event Type
- Malfunction
- Date Received
- December 10, 2023
- Date of Event
- November 20, 2023
- Report Date
- August 13, 2024
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- UDI-DI
- 00801741040825
- PMA / PMN Number
- K130366
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON 06-AUG-2024 FROM MDR DATA SYSTEMS TEAM, (B)(6), INDICATING THAT THE INFORMATION (SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D) OF THE PREVIOUSLY SUBMITTED FDA FORM 3500A, WAS INCORRECT AND A REQUEST WAS MADE TO SUBMIT SUPPLEMENTAL REPORT(S) WITH THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS IN THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELDS. THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THAT REQUEST. **UDI RELATED DATA QUALITY UPDATES ONLY** THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE DENALI PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE SIMILAR DENALI PRODUCT IS IDENTIFIED IN D2 (PROCODE) AND G4 (PMA/510(K)). D4: MEDICAL DEVICE EXPIRATION DATE- 2026-01-28. D4: UDI-(B)(4). G4: K240257, K160866, K143208, K130366. H4: DEVICE MANUFACTURER DATE: 2023-02-01.
H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. TWO FLUOROSCOPIC IMAGES WERE REVIEWED. ONE OF THE IMAGES IS CONTRAST-ENHANCED AND DEMONSTRATES A SEGMENT OF INFERIOR VENA CAVA WITH UNUSUALLY IRREGULAR WALL CONTOURS. BOTH IMAGES DEPICT THE INCOMPLETELY DEPLOYED FILTER. ONE VIDEO WAS REVIEWED. THE VIDEO IS POOR QUALITY AND DOES NOT CLEARLY DEPICT THE POST-DEPLOYMENT STATUS OF THE FILTER. A CONTRAST-ENHANCED VENA CAVOGRAM IS NOT PROVIDED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED EXPANSION FAILURE AS THE IMAGES SHOW THE FILTER INCOMPLETELY DEPLOYED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EXPANSION FAILURE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: D4 (EXPIRY DATE: 01/2026), G3, H6 (METHOD). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, IMAGES AND VIDEOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 01/2026). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE, THE FILTER ALLEGEDLY DID NOT DEPLOY COMPLETELY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY STUCK TOGETHER AFTER DEPLOYMENT. REPORTEDLY, A GUIDEWIRE WAS USED TO OPEN THE FILTER. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE, THE FILTER ALLEGEDLY DID NOT DEPLOY COMPLETELY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY STUCK TOGETHER AFTER DEPLOYMENT. REPORTEDLY, A GUIDEWIRE WAS USED TO OPEN THE FILTER. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE, THE FILTER ALLEGEDLY DID NOT DEPLOY COMPLETELY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY STUCK TOGETHER AFTER DEPLOYMENT. REPORTEDLY, A GUIDEWIRE WAS USED TO OPEN THE FILTER. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274079 | DENALI FEMORAL SYSTEM | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFHN0928 | 00801741040825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |