SMALL PERIPHERAL CUTTING BALLOON?
Report
- Report Number
- 2134265-2014-05858
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- LOX
- PMA / PMN Number
- P950020
- 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 MFR.; THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON PROTECTOR WAS RETURNED OVER THE DETACHED BALLOON. THERE WAS NO DAMAGE NOTED TO THE BALLOON PROTECTOR. THE RETURNED BALLOON PROTECTOR INNER DIMENSION WAS MEASURED AND WAS WITHIN SPECIFICATION. THE INNER LUMEN HAD DETACHED AT THE DISTAL TIP/BALLOON BOND. THE OUTER LUMEN HAD DETACHED AT THE PROXIMAL BALLOON BOND. THIS RESULTED IN A COMPLETE DETACHMENT OF THE BALLOON FROM THE DELIVERY SYSTEM. THE DISTAL TIP/BALLOON BOND LENGTH AND THE PROXIMAL BALLOON BOND WERE MEASURED ARE WERE FOUND TO BE WITHIN SPECIFICATION. THE MARKERBANDS REMAINED ON THE DISTAL SECTION OF THE INNER LUMEN. NO DAMAGE WAS NOTED TO THE CATHETER SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).
IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED DURING PREPARATION. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON¿ BALLOON CATHETER WAS SELECTED TO TREAT THE LESION. DURING PREPARATION, PHYSICIAN ATTACHED AN INFLATION DEVICE/SYRINGE TO THE CATHETER AND DRAW BACK TO ITS FULL VOLUME DEFLATING THE BALLOON TO REMOVE ALL AIR FROM THE BALLOON PRIOR TO BALLOON PROTECTOR REMOVAL HOWEVER, BALLOON CAME OFF TOGETHER WITH THE PROTECTOR OUTSIDE THE PATIENT'S BODY. TWO BALLOON MARKERS HAD BEEN REMAINED ON THE SHAFT AND STRONG RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE PROTECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PROTECTOR OF THE SECOND DEVICE WAS ABLE TO BE REMOVED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD.
IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED DURING PREPARATION. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON¿ BALLOON CATHETER WAS SELECTED TO TREAT THE LESION. DURING PREPARATION, PHYSICIAN ATTACHED AN INFLATION DEVICE/SYRINGE TO THE CATHETER AND DRAW BACK TO ITS FULL VOLUME DEFLATING THE BALLOON TO REMOVE ALL AIR FROM THE BALLOON PRIOR TO BALLOON PROTECTOR REMOVAL HOWEVER, BALLOON CAME OFF TOGETHER WITH THE PROTECTOR OUTSIDE THE PATIENT'S BODY. TWO BALLOON MARKERS HAD BEEN REMAINED ON THE SHAFT AND STRONG RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE PROTECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PROTECTOR OF THE SECOND DEVICE WAS ABLE TO BE REMOVED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613113 | SMALL PERIPHERAL CUTTING BALLOON? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - GALWAY | M001BPM4015140F0 | 16946733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GUIDEWIRE:CRUISE| INFLATION DEVICE:EVEREST| INTRODUCER SHEATH:TERUMO 6FR |