MAUDE Adverse Event Report: COOK INC COONS INTERVENTIONAL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G02621
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code: dqx wire, guide, catheter.Pma/510(k) number: pre-amendment.Investigation: evaluation: reviews of the complaint history, device history record, drawing, manufacturer¿s instructions, quality control procedures, and a functional test & visual inspection of the returned device were conducted during the investigation.The device in question was not returned for investigation.However, 31 devices were returned in unused, unopened condition for investigation.The devices appeared to have welds on the distal tip, no mandril or safety wire protrusions, and no apparent nonconformance's.The distal end of each wire guide was tugged forcefully during the functional test, and all remained intact and maintained form.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 did reveal one nonconforming event which could contribute to this failure mode.This nonconformance was for incorrect coil tension.While this nonconformance is potentially related to the reported failure, it should be noted that the effected unit was scrapped from the lot and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
As reported, during an unknown procedure involving a patient of unknown age and gender, a coons interventional wire guide "broke" on a "biliary patient".Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

• Brand Name: COONS INTERVENTIONAL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8861180
• Report Number: 1820334-2019-01936
• Device Sequence Number: 3294897
• Product Code: DQX
• UDI-Device Identifier: 00827002026216
• UDI-Public: (01)00827002026216(17)240523(10)9697064
• 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
• Report Date (Section B): 08/05/2019

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 Expiration Date: 05/23/2024
• Device Model Number: G02621
• Device Catalogue Number: THSF-35-180-COONS
• Device Lot Number: 9697064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1