MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA4-18-135-6-10

Device Problems Kinked (1339); Occlusion Within Device (1423); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2015

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 the advance 18 lp low profile balloon catheter was inflated to 12 atm (atmospheres) inside the patient after using a crossover approach, but when the balloon was deflated and removal was attempted, the wire kinked and the two components became stuck together.It was also later noted that the catheter was occluded.The wire and balloon catheter had to be removed together, and there were no injuries or additional procedures reported.

• Brand Name: ADVANCE 18 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: 7592429
• MDR Text Key: 111309906
• Report Number: 1820334-2018-01783
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002502533
• UDI-Public: (01)10827002502533(17)180501(10)5849506
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA4-18-135-6-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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