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

Catalog Number	THSF-35-180-COONS
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a avf (arteriovenous fistula) declot of the upper extremity the device unraveled and got stuck in the avf balloons.It is reported the wire got stuck in the balloon catheter and as the physician pulled harder on the wire, it began to come unwound.Everything was able to retrieved during the same procedure.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned 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: 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: 5928878
• Report Number: 1820334-2016-00879
• Device Sequence Number: 16381816
• Product Code: DXQ
• UDI-Device Identifier: 00827002026216
• UDI-Public: (01)00827002026216(17)210609(10)6973407
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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 Catalogue Number: THSF-35-180-COONS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2016
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1