SMALL PERIPHERAL CUTTING BALLOON¿
Report
- Report Number
- 2134265-2013-00688
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 22, 2013
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- LOX
- PMA / PMN Number
- P950020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION SHOWED THE COMPLAINT DEVICE WAS RETURNED ON A GUIDEWIRE. THE GUIDEWIRE HAD ENTERED THE TIP, AND EXITED THE GUIDEWIRE LUMEN SUCCESSFULLY. SLIGHT GUIDEWIRE MOVEMENT WAS PRESENT AT THE TIP AND AT THE GUIDEWIRE EXIT PORT, HOWEVER, FURTHER EXAMINATION IDENTIFIED THAT THE SHAFT WAS BUNCHED/ACCORDIONED FROM 70-95MM INCLUSIVE FROM THE CATHETER TIP, AND THAT THE INNER LUMEN WAS STUCK TO THE GUIDEWIRE AT THIS SECTION. AT THE DAMAGED LOCATION, A SECTION OF THE OUTER LUMEN WAS CUT LENGTHWISE DURING ANALYSIS. SUBSEQUENTLY, THE INNER WAS CUT FOR THE SAME LENGTH DURING ANALYSIS AT THIS AREA ALSO. THE GUIDEWIRE WAS STUCK TO THE GUIDEWIRE LUMEN AT THIS SECTION, AND CONGEALED/HARDENED BLOOD AND CONTRAST MEDIA WAS PRESENT ALSO. FURTHER ANALYSIS CONFIRMED THAT THE GUIDEWIRE WAS STUCK WITHIN THE GUIDEWIRE LUMEN DUE TO A BUILD-UP OF CONGEALED/HARDENED BLOOD AND CONTRAST MEDIA WITHIN THE GUIDEWIRE LUMEN WHICH IN TURN CAUSED RESTRICTED MOVEMENT OF THE GUIDEWIRE DURING ATTEMPTED REMOVAL OF THE DEVICE. THE BALLOON AND TIP SECTIONS WERE MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. 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).
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).
SAME CASE AS MDR ID # 2134265-2013-00696. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, REMOVAL DIFFICULTY OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT FOREARM SHUNT. ACCESS WAS OBTAINED VIA LEFT CUBITAL REGION WITH A 6FR NON-BSC SHEATH. A 0.014'' TRANSCEND GUIDE WIRE WAS ADVANCED TO THE LESION. THE 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS THEN ADVANCED AND THE LESION WAS DILATED AT 6ATM. THE PHYSICIAN ATTEMPTED TO REMOVE THE CUTTING BALLOON FROM THE PATIENT, BUT THE CUTTING BALLOON COULD NOT BE REMOVED. THE PHYSICIAN FELT THAT THE CUTTING BALLOON WAS STUCK WITH THE GUIDE WIRE. THE CUTTING BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER AS A UNIT FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.
SAME CASE AS MDR ID # 2134265-2013-00696. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, REMOVAL DIFFICULTY OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT FOREARM SHUNT. ACCESS WAS OBTAINED VIA LEFT CUBITAL REGION WITH A 6FR NON-BSC SHEATH. A 0.014 TRANSCEND GUIDE WIRE WAS ADVANCED TO THE LESION. THE 4.00 MM/1.5 CM/140 CM SMALL PERIPHERAL CUTTING BALLOON WAS THEN ADVANCED AND THE LESION WAS DILATED AT 6 ATM. THE PHYSICIAN ATTEMPTED TO REMOVE THE CUTTING BALLOON FROM THE PATIENT, BUT THE CUTTING BALLOON COULD NOT BE REMOVED. THE PHYSICIAN FELT THAT THE CUTTING BALLOON WAS STUCK WITH THE GUIDE WIRE. THE CUTTING BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER AS A UNIT FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64388 | SMALL PERIPHERAL CUTTING BALLOON¿ | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - GALWAY | M001BPM4015140F0 | 15452466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRANSCEND 0.014" GUIDE WIRE| TERUMO 6FR INTRODUCER SHEATH |