BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
|
Back to Search Results |
|
Model Number 7590 |
Device Problems
Material Rupture (1546); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/26/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, during the second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.It was further noted that the device was kinked due to angulation when crossing the lesion.The procedure was completed with another of same device.No patient complications were reported and the patient condition was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the inflation lumen, and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.At 4mm from the tip of the device there was a longitudinal tear for a length of 22mm running proximal to the tip.Product analysis confirmed the reported burst as the device had a longitudinal tear in the balloon.However, analysis could not confirm the reported kink as there was no further damage found to the device.
|
|
Event Description
|
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, during the second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.It was further noted that the device was kinked due to angulation when crossing the lesion.The procedure was completed with another of same device.No patient complications were reported and the patient condition was stable.
|
|
Search Alerts/Recalls
|
|
|