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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation- a review of the complaint history, device history record, quality control and visual inspection of the returned device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.One bentson straight fixed core wire guide was returned for evaluation.Inspection of the device noted that the wire had a wavy effect starting at 6cm from the distal tip.The distal tip had a wire sticking out from the coils at approximately 7.5 from the distal tip.No other remarkable damage was noted.The noted condition of the returned device is possibly related to user technique and/or product handling during usage.
Event or Problem Description
It was reported, the iliac of an arteriosclerotic vascular disease (asvd) patient was to be stented but the bentson straight fixed core wire guide broke during usage.The sharp metallic thread was exposed from the root of the soft tip.There was no harm caused to the patient; no fragments were within the patient.No additional details have been received.

• Brand Name: BENTSON STRAIGHT 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: 6349153
• Report Number: 1820334-2017-00283
• Device Sequence Number: 663601
• Product Code: DXQ
• UDI-Device Identifier: 00827002010956
• UDI-Public: (01)00827002010956(17)210103(10)6446514
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2017

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 Model Number: N/A
• Device Catalogue Number: TSFB-35-200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1