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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected information: product code: dqx.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A bentson plus fixed core wire guide was used during an unspecified procedure.It was reported that the inner mandril was sticking out.No other information was provided.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
Additional information: patient and procedural information was requested; however the information was unknown and unable to be provided.Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used bentson plus fixed core wire guide was returned for evaluation.Inspection of the device noted that the distal end of the safety wire is exposed approximately 1.0cm at 149.5cm from the proximal end.Distal weld is present and intact.The device outer diameter measured within specifications.The mandril was not protruding.The device history record was reviewed and noted two nonconformances that could be related to the reported issue; however all nonconforming product was scrapped prior to completion of the final lot.There were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6937392
• Report Number: 1820334-2017-03532
• Device Sequence Number: 10933604
• Product Code: DQX
• UDI-Device Identifier: 00827002097353
• UDI-Public: (01)00827002097353(17)220827(10)8097914
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1