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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a lower extremity arteriogram procedure on a (b)(6) year old female patient, the guide wire broke off inside the catheter.The facility had to snare the broken portion to successfully retrieve the broken piece from the patient¿s anatomy.Another device from an unknown manufacturer was opened and used to complete the procedure.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
A review of the complaint history, drawings, device history record, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One bentson straight heparin coated fixed core wire guide was returned for investigation.Bends in the wire guide were noted at 5 cm, 3 cm, and 2 cm from the distal end.The safety wire was protruding 1 mm past the distal end and the distal weld is attached to the coil but not completely.Destructive testing was performed to confirm that none of the wire guide was absent.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 no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of the 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 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: 6151894
• Report Number: 1820334-2016-01410
• Device Sequence Number: 18930841
• Product Code: DXQ
• UDI-Device Identifier: 00827002010628
• UDI-Public: (01)00827002010628(17)210923(10)7264312
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/07/2017

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 Model Number: N/A
• Device Catalogue Number: TSFB-35-260-BH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 06/07/2017
• 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: Required Intervention
• Patient Age: 59 YR