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	11/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.(b)(4).Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The bentson plus fixed core wire guide was returned in a used, damaged condition.Visual inspection revealed that the coil was stretched for a distance of 4.0mm at 13.0cm from the distal end.The welds at the distal and proximal ends were intact with no defects in the coating noted.A document-based investigation evaluation was also performed.A review of the device history record noted non-conformances for the failures "damaged"; "mandril, catching", "coil, offset"; and "wire broken".This is the second reported complaint for this lot number.Based on the information provided and results of the investigation, a definitive root cause to the reported event could not conclusively be determined.Per the risk assessment, no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported that after getting access with a 19ut gage needle via the right femoral artery (fa), the bentson plus fixed core wire guide was inserted.The physician felt resistance and upon withdrawal noted that the tip was unraveling.Another bentson wire was used to successfully complete the procedure.There was no reported adverse event or injury to the patient.

• 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: 6723365
• Report Number: 1820334-2017-02066
• Device Sequence Number: 16454740
• Product Code: DQX
• UDI-Device Identifier: 00827002097353
• UDI-Public: (01)00827002097353(17)210902(10)7221417
• 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: health professional,user faci
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1