DENALI FEMORAL SYSTEM
Report
- Report Number
- 2020394-2023-01294
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- November 27, 2023
- Report Date
- August 13, 2024
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- UDI-DI
- 00801741040801
- PMA / PMN Number
- K130366
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED AS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED ADVERSE EVENT 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. 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.
OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON (B)(6) 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. D4: MEDICAL DEVICE EXPIRATION DATE- ALTHOUGH THE LOT NUMBER WAS REQUESTED, IT WAS NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE EXP DATE IS NA. G4: K240257, K160866, K143208, K130366.
H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
IT WAS REPORTED THAT SOMETIMES POST A VENA CAVA FILTER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION AND ARTHRITIC SORE IN THE LEG. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED THAT SOMETIMES POST A VENA CAVA FILTER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION AND ARTHRITIC SORE IN THE LEG. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED THAT SOMETIMES POST A VENA CAVA FILTER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION AND ARTHRITIC SORE IN THE LEG. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2017364 | DENALI FEMORAL SYSTEM | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | UNKNOWN | 00801741040801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |