MAUDE Adverse Event Report: COOK INC SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSCF-35-260-3
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field for d2b was not populated due to a technical limitation.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
It was reported that in multiple cases involving the safe-t-j exchange fixed core wire guide, the j-tip would not regain its shape after insertion through the catheter, and it seemed as if the inner mandril was either extremely weak or breaking inside the wire.There were no injuries or additional procedures reported.

• Brand Name: SAFE-T-J 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: 7914260
• Report Number: 1820334-2018-03034
• Device Sequence Number: 19297513
• Product Code: DQX
• UDI-Device Identifier: 00827002005174
• UDI-Public: (01)00827002005174(17)210802(10)7123536
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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: 08/02/2021
• Device Catalogue Number: TSCF-35-260-3
• Device Lot Number: 7123536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1