ATLAS GOLD
Report
- Report Number
- 2020394-2023-01037
- Event Type
- Malfunction
- Date Received
- November 14, 2023
- Date of Event
- October 9, 2023
- Report Date
- July 16, 2024
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- UDI-DI
- 00801741061028
- PMA / PMN Number
- K181323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 03/2026). 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: ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINANT INDICATED THAT THERE WAS NO VESSEL DAMAGE, NO DETACHMENT OF THE DEVICE, AND NO DIFFICULTY RETRACTING THE DEVICE THROUGH THE INTRODUCER SHEATH; THEREFORE, THIS EVENT CAN BE DEEMED A NON-COMPLICATED BALLOON RUPTURE AND IS NO LONGER REPORTABLE. HOWEVER, OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON 8-JULY-2024 FROM MDR DATA SYSTEMS TEAM, LATANIA PARKER, 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. H11: D2: MEDICAL DEVICE TYPE-LIT; DQY D4: MEDICAL DEVICE EXPIRATION DATE- 03/09/2026 D4: UDI- (B)(4). H4: DEVICE MANUFACTURE DATE- 03/09/2023 G4: K122984;K181323.
H10: ADDITIONAL INFORMATION WAS RECEIVED AND THE FILE WAS REASSESSED FOR REPORTABILITY, AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. H10: D4 (EXPIRY DATE: 03/2026), 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. DEVICE PENDING RETURN/
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR AN AORTIC VALVE REPLACEMENT, VIA THE FEMORAL ACCESS, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE PUNCTURED WITH A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT ANGIOPLASTY PROCEDURE IN THE FEMORAL ROUTE, THE BALLOON WAS ALLEGEDLY PUNCTURED WITH A HOLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR AN AORTIC VALVE REPLACEMENT, VIA THE FEMORAL ACCESS, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE PUNCTURED WITH A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2041795 | ATLAS GOLD | PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | 93PH0195 | 00801741061028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |