FDA Adverse Event
Malfunction
Summary report: N
STERLING MONORAIL
MDR report key: 1426631
·
Received April 8, 2009
Report
- Report Number
- 2134265-2009-01511
- Event Type
- Malfunction
- Date Received
- April 8, 2009
- Date of Event
- March 11, 2009
- Report Date
- March 11, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQY
- PMA / PMN Number
- K053118
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4)
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURED OCCURRED. THE 99% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). UPON THE 1ST INFLATION UP TO 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. PATIENT CONDITION LISTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERLING MONORAIL | DQY CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC | NA | 12092393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |