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

Catalog Number	TSFB-35-145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
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
It was reported that during a drainage procedure, the physician felt resistance while inserting the bentson straight fixed core wire guide and noticed that it was broken into two portions at the distal part.The wire guide was immediately withdrawn from the patient with the pigtail drainage catheter.The procedure was successfully completed with a new guide wire and catheter.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used bentson straight fixed core wire guide was returned for investigation.The distal end of the wire guide is separated.The distal separated section is 5.9 cm in length.The proximal section is 141.8 cm in length.The separation site has sharp edges.The wire guide outer diameter measured within specifications.The mandril wire measured within specifications.The safety wire was caught securely in the tip and back welds.The weld at the proximal end is caught, smooth, not sharp or offset and distal tip is smooth, not sharp or offset.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirement, each wire guide is 100% inspected and verified prior to release.Review of the device history record of the finished product shows no nonconforming events.In addition, there were no other reported complaints for this lot number.There is no information regarding the patient anatomy or angulation that may have contributed to this event.There is mention of resistance however and this may have contributed to the separation.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was human anatomy related but other compatible device related factors cannot be ruled out.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and 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: 7061256
• Report Number: 1820334-2017-04241
• Device Sequence Number: 13720477
• Product Code: DQX
• UDI-Device Identifier: 00827002006911
• UDI-Public: (01)00827002006911(17)220605(10)7898597
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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 Catalogue Number: TSFB-35-145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1