FDA Adverse Event
Malfunction
Summary report: N
ATHLETIS PTA BALLOON DILATATION CATHETER
MDR report key: 16515492
·
Received March 9, 2023
Report
- Report Number
- 2124215-2023-07944
- Event Type
- Malfunction
- Date Received
- March 9, 2023
- Date of Event
- February 16, 2023
- Report Date
- March 9, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729974055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL PRO CODE (PRODUCT CODE): DQY.
Description of Event or Problem · 0
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0MM X 40MM X 75CM ATHLETIS PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION OF THE TARGET LESION LOCATED IN A FISTULA. HOWEVER, THE BALLOON RUPTURED DURING INFLATION AT 22 ATMOSPHERES. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164491 | ATHLETIS PTA BALLOON DILATATION CATHETER | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 39347-080470 | 0029219332 | 08714729974055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |