MUSTANG¿
Report
- Report Number
- 2134265-2013-02051
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- LIT
- PMA / PMN Number
- K103751
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MFR: THE BALLOON WAS RETURNED. DURING AN ATTEMPT TO INFLATE THE BALLOON, A PINHOLE LEAK WAS IDENTIFIED. THE LEAK WAS LOCATED AT 1MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND THE DISTAL MARKERBAND COULD NOT IDENTIFY ANY ANOMALIES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).
AGE AT TIME OF EVENT: THE PATIENT WAS UNDER 18 YEARS. (B)(4).
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE FOR TREATMENT, BALLOON BURST OCCURRED. THE ACCESS WAS GAINED VIA FEMORAL ARTERY. A MUSTANG 4.0 X 40MM BALLOON WAS USED IN AN ILIAC ARTERY. IT WAS INFLATED TO 14ATM AND BURST. NO PATIENT COMPLICATION HAS BEEN REPORTED.
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE FOR TREATMENT, BALLOON BURST OCCURRED. THE ACCESS WAS GAINED VIA FEMORAL ARTERY. A MUSTANG 4.0 X 40MM BALLOON WAS USED IN AN ILIAC ARTERY. IT WAS INFLATED TO 14ATM AND BURST. NO PATIENT COMPLICATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124791 | MUSTANG¿ | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC - GALWAY | H74939171040470 | 0015374995 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |