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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the tip of the device separated.A new device was opened and used to complete the procedure.The device separation occurred outside of the patients body therefore a section of the device did not remain inside the patient¿s body.Additional information has been requested but not provided at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation a review of the drawings, dimensional verification, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The instructions for use advise to inspect the product upon removal from package to ensure no damage has occurred.One approach cto microwire wire guide was returned for evaluation.Inspection of the device noted the tip of the wire to be damaged and the solder tip still intact.The coil (distal) end of the wire guide was kinked.The wire guide had no notable damage and was smooth to the touch.The coil tip was intact; it was measured within specification.A definitive root cause cannot be determined.Monitoring will continue to be performed for similar complaints.Per the quality engineering risk assessment, no further action is warranted.The device has been archived at the manufacturing facility.

• 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: 6249219
• Report Number: 1820334-2017-00107
• Device Sequence Number: 19060976
• Product Code: DXQ
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)210623(10)7434781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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-14-300-12G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 06/05/2017
• Patient Sequence Number: 1