MAUDE Adverse Event Report: COOK INC SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G03565
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2015
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
It was reported that when the physician attempted to remove the introducer (the procedure was abandoned for physiological reasons), the nylon split and the amplatz coils began to unravel.The devices were removed as a unit, no fragments were left in the patient, and there were no injuries or additional procedures reported.It was further confirmed that the coating was torn and the coil was elongated.

• Brand Name: SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7894603
• Report Number: 1820334-2018-02978
• Device Sequence Number: 183152
• Product Code: DQX
• UDI-Device Identifier: 00827002035652
• UDI-Public: (01)00827002035652(17)200109(10)5527006
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: 01/09/2020
• Device Model Number: G03565
• Device Catalogue Number: THSCF-35-180-3-AES
• Device Lot Number: 5527006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1