QUANTUM MAVERICK BALLOON CATHETER
Report
- Report Number
- 2134265-2010-04701
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 3, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- P860019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).
DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED QUANTUM MAVERICK MR DEVICE REVEALED THE PRESENCE OF DRIED BLOOD AND CONTRAST THROUGHOUT THE DISTAL SHAFT. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE CATHETER REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL. THE TEAR WAS APPROXIMATELY 10MM IN LENGTH BEGINNING AT PROXIMAL END OF DISTAL MARKER BAND CONTINUING PROXIMALLY TO APPROXIMATELY 13MM FROM DISTAL TIP. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. EXAMINATION OF THE DISTAL END OF THE DEVICE REVEALED DAMAGE TO THE DISTAL TIP. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE TIP DAMAGE. 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 PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). ANOTHER MANUFACTURER'S STENT WAS IMPLANTED IN SEPTEMBER AND IT WAS NOTED THAT THERE WAS AN INDENTATION AND THE STENT APPOSITION WAS NOT GOOD. SOME RESISTANCE WAS ENCOUNTERED UPON ATTEMPTING TO INTRODUCE AND CROSS THE LESION WITH THE 15MM X 4.0MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER. THE BALLOON RUPTURED AT 10ATMS ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). ANOTHER MANUFACTURER'S STENT WAS IMPLANTED IN SEPTEMBER AND IT WAS NOTED THAT THERE WAS AN INDENTATION AND THE STENT APPOSITION WAS NOT GOOD. SOME RESISTANCE WAS ENCOUNTERED UPON ATTEMPTING TO INTRODUCE AND CROSS THE LESION WITH THE 15MM X 4.0MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER. THE BALLOON RUPTURED AT 10ATMS ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS 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 | H7493808015400 | 12300696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GUIDE WIRE: WHISPER LS| INTRODUCER SHEATH: 6F TERUMO| GUIDE CATHETER: 6F BRITE TIP AL1| INFLATION DEVICE: ENCORE26 |