MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT CEREBRAL HEPARIN COATED FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSFB-35-80-BH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This information was received from a medwatch report with uf/importer report #: (b)(4).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 bentson straight cerebral heparin coated fixed core wire guide unraveled upon removal from a seroma, so another wire was used to place the drain successfully.No pieces of the wire were retained inside the patient.It was further noted that the weld connection disconnected from the coil and safety wire which resulted in coil elongation.The product problem did not result in any reported serious injuries to the patient.

• Brand Name: BENTSON STRAIGHT CEREBRAL HEPARIN COATED 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: 7907413
• Report Number: 1820334-2018-02915
• Device Sequence Number: 856840
• Product Code: DQX
• UDI-Device Identifier: 00827002017504
• UDI-Public: (01)00827002017504(17)201118(10)6329603
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 11/18/2020
• Device Catalogue Number: TSFB-35-80-BH
• Device Lot Number: 6329603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR