MAUDE Adverse Event Report: COOK INC FLOW-DIRECTED BALLOON CATHETER; DYG CATHETER, FLOW DIRECTED

Catalog Number	FDB5.3-35-80
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2015
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 balloon on the flow-directed balloon catheter would not inflate, so another device of the same kind was used to complete the occlusion procedure.It was further noted that the tip of the balloon had a leak, and the material was pulling away at the distal end of the balloon causing the failure.This product problem did not result in any reported serious injuries to the patient.

• Brand Name: FLOW-DIRECTED BALLOON CATHETER
• Common Device Name: DYG CATHETER, FLOW DIRECTED
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8169186
• Report Number: 1820334-2018-03799
• Device Sequence Number: 13890182
• Product Code: DYG
• UDI-Device Identifier: 00827002108516
• UDI-Public: (01)00827002108516(17)150820(10)5224750
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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 Expiration Date: 08/20/2015
• Device Catalogue Number: FDB5.3-35-80
• Device Lot Number: 5224750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1