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 Consequences Or Impact To Patient (2199)
Date of Event	04/28/2015
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 safe-t-j amplatz extra-stiff support heparin coated wire guide was used during the bav (balloon aortic valvuloplasty) procedure.The physician noted an issue after applying torque and inserting the device tip inside of the left ventricle.The device was removed from the patient, and it was noted that the core wire protruded from the outer spring coil.Another device with the same specifications was used to complete the procedure without any problem.It was further noted that the distal weld connection separated from the coil and safety wire, but the product problem did not result in any reported serious injuries to the patient.

• 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: 7889897
• Report Number: 1820334-2018-02888
• Device Sequence Number: 19262959
• Product Code: DQX
• UDI-Device Identifier: 00827002116849
• UDI-Public: (01)00827002116849(17)200106(10)5508640
• 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: 01/06/2020
• Device Catalogue Number: THSCF-35-260-3-AES-SGH-BH
• Device Lot Number: 5508640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• 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