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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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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
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.

 
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Brand NameADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
8123392235
MDR Report Key3674396
Report Number1820334-2014-00085
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 02/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2016
Device Catalogue NumberPTAX4-14-170-3-20
Device LOT Number4651837
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/10/2014
Device Age2 mo
Event Location Hospital
Date Manufacturer Received02/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/04/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2014 Patient Sequence Number: 1
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