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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC APPROACH CTO MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER
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COOK INC APPROACH CTO MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER Back to Search Results
Model Number G50792
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/21/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The field for section was not populated due to a technical limitation.Section product code: dqx.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
It was reported that the distal tip of the guide wire was exhibiting resistance while moving through the catheter.There were no injuries or additional procedures reported.It was further confirmed that the tip had begun to unravel.
 
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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 Key7895172
Report Number1820334-2018-02983
Device Sequence Number11121372
Product Code DQX
UDI-Device Identifier00827002507920
UDI-Public(01)00827002507920(17)170601(10)3542864
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/20/2018
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 Expiration Date06/01/2017
Device Model NumberG50792
Device Catalogue NumberCMW-14-300-18G
Device Lot Number3542864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2018
Initial Report FDA Received Date09/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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