MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G26900

Device Problems Hole In Material (1293); Inflation Problem (1310); Material Rupture (1546)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 03/23/2015

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

The atb advance balloon catheter was used for the "evt".The physician advanced the complaint balloon over the wire guide, but the balloon would not inflate more than 6 atm (atmospheres).The physician confirmed the pinhole at the balloon by the angiography and suggested that the balloon rupture was due to calcification in the lesion.The complaint device was replaced with another device of the same kind, and the procedure was completed without problems.There were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: ATB ADVANCE 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: 7589468
• MDR Text Key: 111094288
• Report Number: 1820334-2018-01788
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002269002
• UDI-Public: (01)00827002269002(17)151001(10)4549303
• 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: 06/11/2018

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 Model Number: G26900
• Device Catalogue Number: ATB5-35-80-7-4.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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