COOK, INC. ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
|
Back to Search Results |
|
Catalog Number PTAX4-14-170-3-20 |
Device Problem
Balloon rupture (1049)
|
Patient Problem
Nonresorbable materials, unretrieved in body (2276)
|
Event Date 02/10/2014 |
Event Type
Injury
|
Event Description
|
A (b)(6) female with peripheral vascular disease underwent right lower extremity revascularization on (b)(6) 2014.Balloon burst.A piece of the device was unable to be retrieved.Per received complaint form ((b)(6) 2014): the doctor performed recanalization of heavily calcified distal superficial femoral artery/popliteal artery occlusion.During inflation, the heavily calcified plaque ruptured balloon (and assume fractured the catheter).Following removal of the pta catheter, the doctor realized the distal catheter fragment remained in the artery.The doctor attempted snare retrieval of the intravascular foreign body.The doctor was able to grasp the catheter fragment but it was lodged so tightly the snare fractured during the retrieval attempt.The catheter fragment remained in the occluded artery and no further attempts were made for retrieval.The patient lower extremity perfusion remained at baseline.The reporter did not remember the inflation pressure used during the procedure.The contrast used was visipaque 50:50 mix with heparized saline.The patient's anatomy is tortuous but no severe angulation.There was severe circumferential calcification.
|
|
Manufacturer Narrative
|
(b)(4).Event is still under investigation.
|
|
Search Alerts/Recalls
|
|
|