QUANTUM MAVERICK BALLOON CATHETER
Report
- Report Number
- 2134265-2010-03954
- Event Type
- Malfunction
- Date Received
- September 14, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 23, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- P860019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
DEVICE EVALUATED BY MANUFACTURER- EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED A PINHOLE IN THE BALLOON. THE DEVICE WAS PRESSURIZED WITH AN INFLATION DEVICE TO REVEAL A PINHOLE IN THE DISTAL END OF THE BALLOON LOCATED APPROXIMATELY 1MM DISTALLY OF THE DISTAL EDGE OF DISTAL MARKERBAND. THERE WAS BLOOD PRESENT THROUGHOUT THE DISTAL SHAFT. A THOROUGH INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OR THE DAMAGE TO THE DEVICE. 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).
IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). A 12X3.0MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND WHEN THE BALLOON WAS INFLATED IT RUPTURED AT 12ATMS. THE BALLOON WAS EXCHANGED WITH A NON-BSC BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS LISTED AS GOOD.
IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). A 12X3.0MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND WHEN THE BALLOON WAS INFLATED IT RUPTURED AT 12ATMS. THE BALLOON WAS EXCHANGED WITH A NON-BSC BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS LISTED AS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM MAVERICK BALLOON CATHETER | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - MAPLE GROVE | H7493808012300 | 13428430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SHEEMAN INFLATION DEVICE |