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

Model Number	G26900
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	03/23/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7589468
• Report Number: 1820334-2018-01788
• Device Sequence Number: 1897674
• Product Code: DQY
• UDI-Device Identifier: 00827002269002
• UDI-Public: (01)00827002269002(17)151001(10)4549303
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: G26900
• Device Catalogue Number: ATB5-35-80-7-4.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1