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
(b)(4).This event is currently under investigation.A follow-up report will be generated upon the completion of the investigation.
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: 1820334-2017-02072, 1820334-2017-02073, and 1820334-2017-02114.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.
Additional Manufacturer Narrative
Corrected data: report source.Product code: dqx.Three wire guides were returned mixed, in the same package for evaluation.There is a report associated with each guide wire (1820334-2017-02072, 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.Device 1 was returned not inserted through any device.Device 2 was returned inserted through a unidentified yellow/white torque gage.Device 3 was returned inserted through a white torque gage, and white hub/strain relief and two separated sections of catheter tubing.The hub/strain relief has.014/90cm printed on it.15.9 cm from the proximal end of the hub, catheter is twisted around the wire guide.Catheter is separated at 65.9 cm for a distance of 2.1 cm from the proximal end.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 quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6789153
• Report Number: 1820334-2017-02115
• Device Sequence Number: 162777
• Product Code: DXQ
• UDI-Device Identifier: 00827002507913
• UDI-Public: (01)00827002507913(17)210506(10)7234551
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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
• Initial Date Received by Manufacturer: 07/15/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 08/22/2017
• Patient Sequence Number: 1