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

Catalog Number	THSCF-35-260-3-AES-SGH-BH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2015
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 core wire broke during shaping of the wire tip which resulted in exposure and elongation of the safe-t-j amplatz extra-stiff support heparin coated wire guide.The device was exchanged with another device of the same specifications to continue the tavi (transcatheter aortic valve implantation) procedure.It was further noted that the distal weld connection separated from the coil and safety wire.This product issue occurred prior to patient contact, and it did not result in any reported impact on the procedure.

• Brand Name: SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7888967
• Report Number: 1820334-2018-02881
• Device Sequence Number: 1434423
• Product Code: DQX
• UDI-Device Identifier: 00827002116849
• UDI-Public: (01)00827002116849(17)191201(10)5425821
• 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): 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: 12/01/2019
• Device Catalogue Number: THSCF-35-260-3-AES-SGH-BH
• Device Lot Number: 5425821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• 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