BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
|
Back to Search Results |
|
Model Number 24701 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 2mm x 40mm x 144cm coyote es balloon catheter was advanced for dilation.However, during second inflation at 14 atmospheres for 5 seconds, the balloon ruptured at the proximal part.The device was removed without problem.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was in good condition post procedure.
|
|
Event Description
|
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 2mm x 40mm x 144cm coyote es balloon catheter was advanced for dilation.However, during second inflation at 14 atmospheres for 5 seconds, the balloon ruptured at the proximal part.The device was removed without problem.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was in good condition post procedure.
|
|
Manufacturer Narrative
|
E1 - initial reporter address 1: (b)(6).Device evaluated by manufacturer: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 6mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
|
|
Search Alerts/Recalls
|
|
|