MAVERICK2 BALLOON CATHETER
Report
- Report Number
- 2134265-2011-00088
- Event Type
- Malfunction
- Date Received
- January 27, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 7, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- LOX
- PMA / PMN Number
- P860019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(6). (B)(4).
DEVICE EVALUATED BY MFR.: BLOOD AND CONTRAST WERE VISIBLE THROUGHOUT THE DISTAL LUMEN. AN INFLATION DEVICE WAS USED TO REVEAL A PINHOLE ON THE BALLOON WALL LOCATED ON THE PROXIMAL END OF THE BALLOON 3MM FROM BALLOON WAIST. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH CONFIRMED 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).
SAME CASE AS MFR REPORT #: 2134265-2011-00089. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 90% STENOSED ECCENTRIC DE NOVO LESION MEASURING 2.25-2.75MM IN DIAMETER AND APPROXIMATELY 10MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED AND SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY THAT CONTAINED A BEND OF APPROXIMATELY 90 DEGREES. A 2.25X12MM MAVERICK2 BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 8 ATMS. THE BALLOON RUPTURED ON THE FIRST INFLATION. ANOTHER MAVERICK2 BALLOON WAS ADVANCED TO THE LESION AND INFLATED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 2.5X8MM NC QUANTUM APEX BALLOON TO THE LESION BUT WAS HAVING DIFFICULTY. AFTER CROSSING THE LESION WITH A SECOND WIRE, THE 2.5X8MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 10 ATMS WHEN IT RUPTURED. ANOTHER NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 6 ATMS AND 8 ATMS A TOTAL OF 4 TIMES TO COMPLETE PREDILATION OF THE LESION. SOME RESIDUAL STENOSIS WAS NOTED. DUE TO THE TORTUOUSITY OF THE LESION, THE PHYSICIAN ELECTED TO COMPLETE THE CASE AT THIS TIME. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS GOOD.
SAME CASE AS MFR REPORT #: 2134265-2011-00089. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 90% STENOSED ECCENTRIC DE NOVO LESION MEASURING 2.25-2.75MM IN DIAMETER AND APPROXIMATELY 10MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED AND SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY THAT CONTAINED A BEND OF APPROXIMATELY 90 DEGREES. A 2.25X12MM MAVERICK2 BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 8 ATMS. THE BALLOON RUPTURED ON THE FIRST INFLATION. ANOTHER MAVERICK2 BALLOON WAS ADVANCED TO THE LESION AND INFLATED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 2.5X8MM NC QUANTUM APEX BALLOON TO THE LESION BUT WAS HAVING DIFFICULTY. AFTER CROSSING THE LESION WITH A SECOND WIRE, THE 2.5X8MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 10 ATMS WHEN IT RUPTURED. ANOTHER NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 6 ATMS AND 8 ATMS A TOTAL OF 4 TIMES TO COMPLETE PREDILATION OF THE LESION. SOME RESIDUAL STENOSIS WAS NOTED. DUE TO THE TORTUOUSITY OF THE LESION, THE PHYSICIAN ELECTED TO COMPLETE THE CASE AT THIS TIME. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS 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 | H7493892812220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NEOS RENATO GUIDE WIRE| SEANMAN INFLATION DEVICE| 2.50X8MM NC QUANTUM APEX BALLOON| 2.0X12MM MAVERICK2 BALLOON| BRITE TIP 6F XB3.5 GUIDE CATHETER |