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	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It was reported that the outer coil of a bentson plus fixed core wire guide unraveled during an unknown procedure.It is unknown if this was observed upon removal from package or if it occurred post insertion into a 19 gauge needle while performing a procedure using seldinger technique 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
Corrected information: report source.Product code: dqx.Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control data, and a visual inspection was conducted during the investigation.One bentson plus fixed core wire guide was returned in a used condition.Coil is stretched 4.0 mm, at 10.2 cm from the distal end and 6.0 mm at 14.2 cm from the distal end.One kink is noted 19.8 cm from distal end.Weld at the proximal end is intact.Weld at the distal end is attached to the coil, but not the core.No defects in the coating are noted.39 new tsfbp-35-145 wire guides were also returned in sealed containers.All 39 were inspected and no defects were noted.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Based on the information provided, inspection of the returned product, and the results of our investigation; a definitive root cause could not be determined.

• 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: 6789373
• Report Number: 1820334-2017-02113
• Device Sequence Number: 880971
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 07/18/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1