MAUDE Adverse Event Report: COOK INC APPROACH CTO MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during an antegrade approach to distal superficial femoral artery (sfa) /popliteal chronic total occlusion (cto) for revascularization while using a cto microwire 25g wire guide to push through the chronic total occlusion, that was obviously subintimal, the physician could feel the wire dragging and could see a defect at the tip of the wire when it was removed.The physician then moved to 18g cto wire and noticed the same feeling.The wire tip didn't appear to have a defect, but tissue/blood was on the tip.There was no damage to the vessel reported.No section of the device remained inside the patient's body and the patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Additional information: product code: dqx.A review of the complaint history, device history record, documentation, drawing, quality control, specifications, as well as a visual inspection of the actual device was conducted during this investigation.One used approach cto microwire wire guide was returned with what appears to be biologic material on the distal end.A bend at 280cm from the proximal end was noted.No other nonconformities regarding the guide's surface defects were noted.Distal tip joint was examined for roundness, smoothness and free-of-holes; no non-conformities were noted.The guide outer diameter was within specifications.The guide distal tip core length measured within specifications.The overall length of the wire guide measured within specifications.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 and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: APPROACH CTO MICROWIRE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6608314
• Report Number: 1820334-2017-01298
• Device Sequence Number: 16416208
• Product Code: DXQ
• UDI-Device Identifier: 00827002507920
• UDI-Public: (01)00827002507920(17)190901(10)5473688
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K081337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: CMW-14-300-18G
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1