MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.(b)(4).Investigation - evaluation: a review of the complaint history, device history record, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The bentson plus fixed core wire guide was returned for evaluation.Visual inspection revealed that the wire guide was severely elongated and kinked and the safety wire and mandril wire were exposed from the coils.Measuring from the distal tip of safety wire coil was elongation.The weld ball was present.A document -based investigation evaluation was also performed.A review of the device history record noted one non-conformances for "wire broken/ damaged".There were no other reported complaints 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 during the leg angiogram procedure, the bentson straight fixed core wire guide became stuck and lodged on the.035 balloon catheter.While struggling to remove the wire through the balloon catheter and sheath, the mandril unraveled when it met with resistance.The wire was able to be removed from patient without issue.There was reportedly no harm to the patient.No further information was provided.

• 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: 6734245
• Report Number: 1820334-2017-02067
• Device Sequence Number: 1267563
• Product Code: DQX
• UDI-Device Identifier: 00827002010635
• UDI-Public: (01)00827002010635(17)210816(10)7165480
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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: TSFB-35-260
• 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: 07/21/2017
• Patient Sequence Number: 1