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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A bentson plus fixed core wire guide was used during an unspecified procedure.It was reported that when the wire was wiped down, unraveling was noticed at the distal end.They stopped using the device and there was no harm to the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: device available for evaluation.Corrected data: product code: dqx.A review of the complaint history, dimensional verification, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One bentson plus fixed core wire guide was returned for evaluation.Visual examination showed no damage to the returned wire guide.Further, the device met dimensional requirements.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: BENTSON PLUS 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: 6796663
• Report Number: 1820334-2017-02610
• Device Sequence Number: 964326
• Product Code: DQX
• UDI-Device Identifier: 00827002097353
• UDI-Public: (01)00827002097353(17)220628(10)7942525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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: TSFBP-35-145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1