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 Code Available (3191)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a pad procedure the wire tip separated while crossing the lesion.The tip remained in the patient but was able to be snared and removed.There was no harm to the patient and the procedure was completed with another device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of complaint history, instructions for use (ifu), quality control and specifications was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "for use in facilitating delivery of percutaneous catheters into the peripheral vasculature." "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." this risk is identified in the ifu.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
During a pad procedure, the wire tip separated while crossing the lesion.The tip remained in the patient but was able to be snared and removed.There was no harm to the patient and the procedure was completed with another device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the non-conformance data revealed that none have been recorded on the device history record.Visual inspection of the returned device was conducted during the investigation.The device was returned with a small piece that had been separated with the tip in a slightly bent and curved unraveled appearance.Based on the appearance of this returned device, it was concluded that the tip was manipulated during the user technique.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 5744470
• Report Number: 1820334-2016-00550
• Device Sequence Number: 13466791
• Product Code: DXQ
• UDI-Device Identifier: 00827002507937
• UDI-Public: (01)00827002507937(17)201217(10)6757587
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CMW-14-300-25G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 08/30/2016; 03/27/2017
• 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: Required Intervention