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

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.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT 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 Key: 3674396
• MDR Text Key: 4244307
• Report Number: 1820334-2014-00085
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 4651837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR