Model Number M001PCB8020500 |
Device Problems
Cutter/Blade (777); Material Deformation (2976)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
Malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that blade lifted occurred.
The target lesion was located at subclavian vein.
A 8.
00mmx2.
0cmx50cm peripheral cutting balloon® was selected to treat the target lesion.
The pressure and duration of the total five inflations was unknown.
On the fifth inflation, it was noted that the balloon ruptured and the blade was lifted off the balloon.
No patients complications were reported and the patient was okay.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.
: the device was returned for evaluation.
An examination of the device identified that a blade and pad had lifted off the balloon.
The blade was still attached to the balloon.
5mm of the blade was attached from its distal end.
A pinhole leak was identified at the distal end of a blade.
This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.
No issues were noted on the shaft polymer extrusion profile.
A visual and tactile examination of hypotube found no kinks or damage along the shaft of the device.
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).
|
|
Event Description
|
It was reported that blade lifted occurred.
The target lesion was located at subclavian vein.
A 8.
00mmx2.
0cmx50cm peripheral cutting balloon® was selected to treat the target lesion.
The pressure and duration of the total five inflations was unknown.
On the fifth inflation, it was noted that the balloon ruptured and the blade was lifted off the balloon.
No patients complications were reported and the patient was okay.
|
|
Search Alerts/Recalls
|