FDA Adverse Event
Malfunction
Summary report: N
CHARGER
MDR report key: 9878209
·
Received March 25, 2020
Report
- Report Number
- 2134265-2020-03855
- Event Type
- Malfunction
- Date Received
- March 25, 2020
- Date of Event
- March 18, 2020
- Report Date
- March 25, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729804369
- PMA / PMN Number
- K112697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT SUPERFICIAL ARTERY. A 6.0 X200, 135 CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST AT NOMINAL PRESSURE. THE BALLOON WAS ABLE TO REMOVED AND COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342220 | CHARGER | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24683 | 0024777599 | 08714729804369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |