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

Catalog Number	TSFB-35-145
Medical Device Problem Codes	Flaked (1246); Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a ureteroscopy procedure on a patient of unknown age and gender, the outer layer (green) unraveled exposing the metal wire inside.The coating that unraveled was removed successfully with no harm to the patient.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.The complaint consisted of three wire guides.It is unknown which product contributed to the adverse event.Therefore, all three complaints are reported as malfunctions and adverse events.No images or device were returned; however, during the course of investigation, a review of the complaint history, manufacturing instructions, quality control, specifications and a review of trends was conducted.This device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections during manufacturing and again, prior to transport; therefore, it is plausible to suggest that the wire guide met with resistance beyond its intended design during a procedurally related event.As no product was returned and based on the limited information provided, we are unable to determine with certainty the root cause of this event.The appropriate internal personnel have been notified, and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), no additional risk mitigation is warranted.
Event or Problem Description
During a ureteroscopy procedure on a patient of unknown age and gender, the outer layer (green) unraveled exposing the metal wire inside.The coating that unraveled was removed successfully with no harm to the patient.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5526103
• Report Number: 1820334-2016-00187
• Device Sequence Number: 18957429
• Product Code: DXQ
• UDI-Device Identifier: 00827002006911
• UDI-Public: (01)00827002006911(17)210111(10)6440451
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TSFB-35-145
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2016
• Supplement Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other