DENALI FEMORAL SYSTEM
Report
- Report Number
- 2020394-2023-01297
- Event Type
- Malfunction
- Date Received
- December 20, 2023
- Date of Event
- November 29, 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
- CH
- 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- 2025-09-28. D4: UDI-(B)(4). G4: K240257, K160866, K143208, K130366. H4: DEVICE MANUFACTURER DATE: 2022-10-01.
H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE DENALI FILTER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE DENALI FILTER PRODUCTS IS IDENTIFIED IN D2 AND G4. H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 09/2025). 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.
H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE DENALI FILTER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE DENALI FILTER PRODUCTS IS IDENTIFIED IN D2 AND G4. 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. FOUR PHOTOS WERE REVIEWED. THE FIRST AND SECOND PHOTOS SHOW THE THE DENALI FILTER WHICH IS SEEN EXPANDED WITH NO VISIBLE ANOMALIES. THE THIRD PHOTO SHOWS THE FEMORAL DENALI FILTER KIT. THE PUSHER CATHETER, TOUHY-BORST ADAPTER, FILTER STORAGE TUBE, INTRODUCER SHEATH, DILATOR AND EXPANDED FILTER ARE SEEN. NO ANOMALIES NOTED. THE FOURTH PHOTO SHOWS THE LABELING WHICH MATCHES WITH THE INFORMATION AVAILABLE IN TRACKWISE. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EXPANSION ISSUE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EXPANSION ISSUE 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 (EXPIRATION DATE: 09/2025), G3, H6 (METHOD). H11: H6 (RESULT, CONCLUSION). 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE LEFT SIDE APPROACH, THE FILTER WAS ALLEGEDLY COULD NOT BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE LEFT SIDE APPROACH, THE FILTER WAS ALLEGEDLY COULD NOT BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE LEFT SIDE APPROACH, THE FILTER WAS ALLEGEDLY COULD NOT BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2106277 | DENALI FEMORAL SYSTEM | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFGW2793 | 00801741040825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male |