MAVERICK2 BALLOON CATHETER
Report
- Report Number
- 2134265-2010-04760
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 6, 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 DEVICE REVEALED 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 APPROXIMATELY 13MM FROM DISTAL TIP AND CONTINUED PROXIMALLY. MAGNIFIED EXAMINATION 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. FURTHER EXAMINATION REVEALED NO OTHER DAMAGE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE 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 RADIAL ARTERY. THE 90% STENOSED AND DE NOVO LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A NON-BSC IVUS CATHETER FAILED TO CROSS THE LESION; THEREFORE IN ATTEMPT TO PRE-DILATE THE LESION, THE 15MM X 2.5MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON RUPTURED AT 14ATMS, ON THE THIRD INFLATION. THE BALLOON WAS INFLATED TO 14ATMS ON THE FIRST AND SECOND INFLATION. THE BALLOON CATHETER WAS REMOVED INTACT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS 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 RADIAL ARTERY. THE 90% STENOSED AND DE NOVO LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A NON-BSC IVUS CATHETER FAILED TO CROSS THE LESION; THEREFORE IN ATTEMPT TO PRE-DILATE THE LESION, THE 15MM X 2.5MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON RUPTURED AT 14ATMS, ON THE THIRD INFLATION. THE BALLOON WAS INFLATED TO 14ATMS ON THE FIRST AND SECOND INFLATION. THE BALLOON CATHETER WAS REMOVED INTACT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAVERICK2 BALLOON CATHETER | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - MAPLE GROVE | H7493892815250 | 13240730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IVUS CATHETER: INTRA FORCUS WR| GUIDE CATHETER: 6F MACH1 Q3.5| GUIDE WIRE: RINATO |