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	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation- the returned approach microwire wire guide was examined.There was coil elongated at the distal tip.Coil separation was noted at 1mm and 3cm from distal tip.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.There is no evidence to suggest that product was not manufactured to current specifications.There is no evidence that the device was damaged at opening.According to the current information, there is no time frame during the procedure that the device failure occurred.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique related or human anatomy related.A review of the complaint history, device history record, ifu, quality control and visual inspection of the returned device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.
Event or Problem Description
It was reported, during left leg lower extremity angiogram, the coiling of the tip separated from the approach cto microwire wire guide.It was still connected to wire.Per additional information, there was resistance encountered during the removal.As the wire being removed through a cxi catheter.No additional information has been received.

• 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: 6396590
• Report Number: 1820334-2017-00386
• Device Sequence Number: 33781
• Product Code: DXQ
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)210805(10)7282651
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

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): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1