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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
The physician was using the wire with a another manufacturer's device and cxi support catheter.Upon attempting to cross cto, the physician noted the wire had broken off.Upon removing the devices used, all devices and device portions came out of the patient.A section of the device did not remain inside the patient铠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
(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, instructions for use (ifu), quality control, specifications and a visual inspection of the returned product was conducted.The visual examination noted that wire guide was fractured.Further examination found that the coating was free of defects such as flaking or peeling.Wire guide is inspected per qc specification, verifying the coated core wire outside diameter is within tolerance and the specified length of overall guide.Prior to sealing of the pouch, an inspector also visually verifies the wire(s) are free from damage.The provided ifu states under precautions "avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel." based on the information provided and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
The physician was using the wire with a another manufacturer's device and cxi support catheter.Upon attempting to cross cto, the physician noted the wire had broken off.Upon removing the devices used, all devices and device portions came out of the patient.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.

• 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: 5483026
• Report Number: 1820334-2016-00120
• Device Sequence Number: 397347
• Product Code: DXQ
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)200721(10)6441868
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/08/2016

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2016
• Supplement Report FDA Received Date: 06/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other