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)
Date of Event	08/31/2017
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 "angio" procedure.It was reported that the inner mandril was sticking out.The wire was reportedly being removed through another instrument; however, the type of instrument is unknown.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
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, review of specifications, quality control, of the returned device was conducted during the investigation.One used bentson plus fixed core wire guide was returned for evaluation and examined.The length of the coil was measured within specifications.The distal weld is connected to the coil but not the core.The proximal weld is present and intact.The mandril is not catching in the coils.The mandril is not exposed.The device history record was reviewed and noted 16 non-conformance's with 15 related to the device failure.13 non-conformance's were related to "offset coil" and relevant to the device failure.1 non-conformance was related to "foreign matter" and not relevant to the device failure.1 non-conformance was related to "kinking" and relevant to the device failure.1 non-conformance was related to "stretched coils" and relevant to the device failure.There is no evidence the mandril was exposed or sticking out.There is no information regarding the patient's anatomical characteristics (e.G., tortuosity, vasoconstriction, calcification) that may have contributed to this event.There is no information regarding other devices used with the tsfbp-35-145 or if these other devices may have met their manufacturing quality specification.There is no information regarding preparation of the device that may have contributed to this event.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique related, other device related or human anatomy related.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: 6931745
• Report Number: 1820334-2017-03530
• Device Sequence Number: 566972
• Product Code: DQX
• UDI-Device Identifier: 00827002097353
• UDI-Public: (01)00827002097353(17)220724(10)8011629
• 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): 11/16/2017

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: 11/09/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1