MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTAX4-14-170-4-12

Device Problem Material Rupture (1546)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 04/20/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that access was gained from the right fa (femoral artery) for crossover approach.The physician advanced the wire guide to the desired lesion and then attempted to dilate with another manufacturer's balloon.The physician then attempted to inflate the advance 14 lp low profile balloon catheter by applying 12-14 atm (atmospheres), but it ruptured.It was further noted that the patient's lesion was partially calcified.Another manufacturer's device was used for the "evt" procedure, and there were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7591580
• MDR Text Key: 111309967
• Report Number: 1820334-2018-01793
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002503387
• UDI-Public: (01)10827002503387(17)171218(10)5528051
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTAX4-14-170-4-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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