MAUDE Adverse Event Report: COOK INC STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSF-35-260
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field for section was not populated due to a technical limitation.Section product code: dqx.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 straight exchange fixed core wire guide was stuck inside of another manufacturer's balloon during patient contact.The wire did not come apart until it was outside of the patient's body.It was further noted that the coil near the distal end of the wire was elongated, and the distal weld connection separated from the safety wire and coil to result in coil elongation.The procedure was completed with a new sheath, and the product problem did not result in any reported serious injuries to the patient.

• Brand Name: STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7889750
• Report Number: 1820334-2018-02885
• Device Sequence Number: 10792802
• Product Code: DQX
• UDI-Device Identifier: 00827002006553
• UDI-Public: (01)00827002006553(17)190825(10)5176506
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/19/2018

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: 08/25/2019
• Device Catalogue Number: TSF-35-260
• Device Lot Number: 5176506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1