BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
|
Back to Search Results |
|
Model Number 3852 |
Device Problems
Material Rupture (1546); Difficult to Advance (2920)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that the balloon ruptured.The target lesion was located in the right coronary artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was felt as the wolverine was delivered into the guide catheter.Eventually, the device was able to advance up to the lesion.However, at first inflation, it was noticed that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
|
|
Event Description
|
It was reported that the balloon ruptured.The target lesion was located in the right coronary artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was felt as the wolverine was delivered into the guide catheter.Eventually, the device was able to advance up to the lesion.However, at first inflation, it was noticed that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.An examination of the balloon identified a longitudinal tear in the balloon.The tear stretched from the distal balloon cone and extended 18 mm proximally along the balloon material.No issues were identified with the balloon material, blades or markerbands which could have contributed to the tear.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found no issues with the hypotube of this device.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.
|
|
Search Alerts/Recalls
|
|
|