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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2017
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
It was reported that during preparation for an unspecified procedure, the coons interventional wire guide was opened, placed into a saline bath and handed to the interventionist.When it was pulled out of the case, the wire unraveled.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used coons lnterventional wire guide was returned for investigation.Visual examination showed the wire guide was returned elongated at the distal end.The coil starts to elongate at 250.7 cm from the proximal end.Also, core wire is exposed and is 259.0 cm in length.Further, solder is attached to coil but not the wire core, at the distal end of wire.In the devices returned state, the device length did not meet requirements.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.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: 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: 6846000
• Report Number: 1820334-2017-02744
• Device Sequence Number: 1117590
• Product Code: DQX
• UDI-Device Identifier: 00827002026223
• UDI-Public: (01)00827002026223(17)220509(10)7811928
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: THSF-35-260-COONS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1