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

Catalog Number	TSFB-35-260
Medical Device Problem Codes	Difficult to Remove (1528); Delamination (2904)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) number: preamendment.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during a fistulogram, the bentson straight fixed core wire guide was unable to be removed from another manufacturer's balloon catheter until it was outside of the patient's anatomy.The wire guide was removed by removing the balloon that the wire was placed through.The green coating of the wire guide was observed to be detached from the wire.Another device was opened and used to successfully complete the procedure.No kinking was noted prior to use of the wire guide; resistance was encountered during removal.The wire guide coating was activated prior to use by dipping the wire in heparinized saline.The wire was placed in a basin with heparinized saline while not in use throughout the procedure.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, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the wire was elongated 3 mm in length, starting at 13.07 cm from the distal end.The coating was missing a distance of 5 mm, starting at a length of 127.9 cm from the proximal end of the device.A bend was noted at a length of 100.5 cm from the proximal end.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows the lot was released meeting all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7334233
• Report Number: 1820334-2018-00420
• Device Sequence Number: 19009383
• Product Code: DQX
• UDI-Device Identifier: 00827002010635
• UDI-Public: (01)00827002010635(17)230102(10)8407364
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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 Catalogue Number: TSFB-35-260
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MUSTANG BALLOON CATHETER