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

Catalog Number	TSFB-35-145-BH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	06/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During a lower extremity atherectomy procedure, when the cook guide wire was removed from the patient, the user found that the wire had broken.According to the initial reporter, the patient had developed an av fistula of sfa during the atherectomy procedure.A stent graft was placed in the patient during procedure.A section of the device did not remain in the patient.
Additional Manufacturer Narrative
(b)(4).(additional information provided/updated): investigation/evaluation: during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, dimensional verification, manufacturing instructions, and a trends of the product was conducted.The wire guide was returned in a used and damaged condition.The visual examination confirmed that the inner mandril had protruded through the coil, approximately 5 mm in length, measuring from the distal weld connection at approximately 7.5 cm.The distal weld connection was intact.This device was inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections during the manufacturing process and again, prior to transport.We are unable to determine with certainty the root cause of the reported difficulty; however, it is plausible to suggest that patient anatomy may have made withdrawal or manipulation of the wire guide difficult.Thus, resulting in damage when the force exceeded design specification during a procedurally related event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
During a lower extremity atherectomy procedure, when the cook guide wire was removed from the patient, the user found that the wire had broken.According to the initial reporter, the patient had developed an av fistula of sfa during the atherectomy procedure.A stent graft was placed in the patient during procedure.A section of the device did not remain in the patient.

• Brand Name: BENTSON STRAIGHT HEPARIN COATED 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: 5792074
• Report Number: 1820334-2016-00579
• Device Sequence Number: 1325900
• Product Code: DXQ
• UDI-Device Identifier: 00827002006928
• UDI-Public: (01)00827002006928(17)210325(10)6758925
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2016

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-BH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 08/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1