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

Model Number	G53024
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2015
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 complainant reported that the coda balloon catheter was used with another manufacturer's device for the evar (endovascular aneurysm repair).The balloon was inflated for touch-up, but the balloon ruptured after several inflations.A longitudinal tear was noted on the complaint device.Another coda balloon catheter was used to complete the procedure, and there were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: CODA BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7601553
• Report Number: 1820334-2018-01802
• Device Sequence Number: 2067072
• Product Code: DQY
• UDI-Device Identifier: 00827002530249
• UDI-Public: (01)00827002530249(17)171106(10)5422147
• 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): 06/14/2018

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: G53024
• Device Catalogue Number: CODA-2-10.0-35-120-32
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1