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

Model Number	N/A
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.(b)(4).A review of the complaint history, device history record, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Three wire guides were returned mixed, in the same package for evaluation.There is a report associated with each guide wire (1820334-2017-02114, and 1820334-2017-02115).The devices were returned together in the same package; therefore we are unable to clarify which wire guide should be applied to which report.Three wires were returned; one of catalog number cmw-14-300-18g and two of catalog number cmw-14-300-12g.One wire guide was lodged inside a cxc catheter (report number 1820334-2017-02073).The wire guide was unable to be removed due to the catheter being twisted on the wire guide at the proximal end.A portion of the catheter was shaved off to expose the distal coils of the wire guide.Bio matter was found on the wire coils and stiffness could not be determined.Another wire guide was damaged at the distal tip.Due to the damage, flexibility of the distal tip could not be determined.Production engineering evaluated the wires and was unable to determine the correct catalog number for each device.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 risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that during a lower leg angiogram, an approach cto microwire wire guide became stuck in the catheter when removing.The same problem was reported with two other wire guides.Each device is being reported and documented in the following report numbers: 1820334-2017-02073, 1820334-2017-02114, and 1820334-2017-02115.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not 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: 6737702
• Report Number: 1820334-2017-02072
• Device Sequence Number: 983651
• Product Code: DQX
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)210611(10)7224211
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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: 07/15/2017
• Initial Report FDA Received Date: 07/24/2017
• Patient Sequence Number: 1