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 Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported, upon opening the packaging of two bentson straight fixed core wire guides, the wire was observed to be frayed approximately 5 inches from the tip.Malfunction observed prior to use.No adverse events have been reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.Two bentson straight fixed core wire guide were returned for evaluation in the shipping holders.The two wire guides had welds attached to the coil but not to the core.Both wire guides are elongated - one elongated in only one location, and the other in two locations of the wire guide.Both wire guides were within specifications for length and diameter.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows twelve (12) nonconforming events that could contribute to this failure mode.The affected parts were scrapped prior to proceeding with the work order.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined; however, the failure could be attributed to shipping/handling of the device.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 6855828
• Report Number: 1820334-2017-02912
• Device Sequence Number: 1324805
• Product Code: DQX
• UDI-Device Identifier: 00827002010635
• UDI-Public: (01)00827002010635(17)220727(10)8003414
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: TSFB-35-260
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1