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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. SAFE-T-J HEPARIN COATED FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER
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COOK, INC. SAFE-T-J HEPARIN COATED FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER Back to Search Results
Catalog Number TSCF-25-145-3-BH
Device Problem Wire(s), breakage of (2347)
Patient Problem Foreign body, removal of (2365)
Event Date 03/05/2014
Event Type  Injury  
Event Description
A pt underwent a percutaneous thrombolytic/dialysis access on (b)(6) 2014.After using the arrow-trerotola device over cook's fixed core wire guide, the doctor believed the wire somehow wrapped around the device.When he went to pull back the wire, he noticed the wire began to come apart and the inner-core stretch.Part of wire was left behind in pt and the pt had to be sent to surgery to retrieve.
 
Manufacturer Narrative
(b)(4).Event evaluation: still under investigation.
 
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Brand Name
SAFE-T-J HEPARIN COATED FIXED CORE WIRE GUIDE
Type of Device
DQX WIRE, GUIDE, CATHETER
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, director
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key3731642
MDR Text Key21531150
Report Number1820334-2014-00137
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2018
Device Catalogue NumberTSCF-25-145-3-BH
Device Lot Number4631384
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/05/2014
Device Age15 MO
Event Location Hospital
Date Manufacturer Received03/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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