FDA Adverse Event
Malfunction
Summary report: N
MUSTANG¿
MDR report key: 3073115
·
Received April 23, 2013
Report
- Report Number
- 2134265-2013-02479
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 25, 2013
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- LIT
- PMA / PMN Number
- K103751
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE FIRST INFLATION OF A 4.0X40 MM MUSTANG BALLOON CATHETER, THE BALLOON RUPTURE AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175370 | MUSTANG¿ | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC - GALWAY | H74939171040470 | 15821972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BALLOON CATHETER: MUSTANG/4-40/5.3/75 |