FLEXTOME? CUTTING BALLOON?
Report
- Report Number
- 2134265-2014-05746
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 25, 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 MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS AND REVEALED A DISTAL SHAFT KINKING AND STRETCHING PRESENT ALONG THE LENGTH OF THE SHAFT. IN ADDITION, THE HYPOTUBE WAS KINKED AT VARIOUS POSITIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. TRACES OF BLOOD WERE VISIBLE IN THE GUIDEWIRE LUMEN INDICATING THE DEVICE HAD BEEN ADVANCED OVER THE GUIDEWIRE. A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE RETURNED BALLOON HAD EVIDENCE OF BEING INFLATED. SOLIDIFIED CONTRAST MEDIUM WAS VISIBLE IN THE INFLATION LUMEN AND BALLOON. A MICROSCOPIC EXAMINATION IDENTIFIED THAT 0.5MM OF THE PROXIMAL END OF A DISTAL BLADE AND BLADE PAD WERE LIFTED FROM THE BALLOON; HOWEVER, NO SECTION WAS DETACHED. IN ADDITION, A DISTAL BLADE WAS BENT. A MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE ADDITIONAL BLADES. THESE BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. NO DAMAGE WAS NOTED TO THE TIP OR BALLOON SECTIONS OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).
IT WAS REPORTED THAT A DIFFICULTY REMOVING BALLOON CATHETER FROM LESION OCCURRED. THE 75% TARGET LESION WAS AN INSTENT RESTENOSIS OF A NON BSC STENT LOCATED IN THE MILDLY CALCIFIED LEFT MAIN CORONARY ARTERY. A 10/3.50 FLEXTOME¿ CUTTING BALLOON¿ MONORAIL WAS USED TO TREAT THE TARGET LESION. A YEAR AND A HALF AGO A 3.5MMX8 NON BSC STENT WAS IMPLANTED IN THE LMT. DURING PROCEDURE, IT WAS NOTED THAT THE LESION WAS HARD AND THAT THE BALLOON CATHETER MET RESISTANCE UPON REMOVAL. AFTER THE BALLOON CATHETER WAS REMOVED, IT WAS NOTED THAT THE STENT WAS ALSO REMOVED. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT APPOSED TO THE VESSEL WALL AND THAT THE STRUT OF THE STENT CAME INTO CONTACT WITH THE CONNECTION PART OF THE BLADE OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY AND NO ADDITIONAL STENT IMPLANTATION WAS PERFORMED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.
IT WAS REPORTED THAT A DIFFICULTY REMOVING BALLOON CATHETER FROM LESION OCCURRED. THE 75% TARGET LESION WAS AN INSTENT RESTENOSIS OF A NON BSC STENT LOCATED IN THE MILDLY CALCIFIED LEFT MAIN CORONARY ARTERY. A 10/3.50 FLEXTOME¿ CUTTING BALLOON¿ MONORAIL WAS USED TO TREAT THE TARGET LESION. A YEAR AND A HALF AGO A 3.5MMX8 NON BSC STENT WAS IMPLANTED IN THE LMT. DURING PROCEDURE, IT WAS NOTED THAT THE LESION WAS HARD AND THAT THE BALLOON CATHETER MET RESISTANCE UPON REMOVAL. AFTER THE BALLOON CATHETER WAS REMOVED, IT WAS NOTED THAT THE STENT WAS ALSO REMOVED. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT APPOSED TO THE VESSEL WALL AND THAT THE STRUT OF THE STENT CAME INTO CONTACT WITH THE CONNECTION PART OF THE BLADE OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY AND NO ADDITIONAL STENT IMPLANTATION WAS PERFORMED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568844 | FLEXTOME? CUTTING BALLOON? | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - GALWAY | H749RB4350100 | 0016322714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |