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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL SAFE-T-J GUIDEWIRE .035"; GUIDEWIRE CARDIAC
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COOK MEDICAL SAFE-T-J GUIDEWIRE .035"; GUIDEWIRE CARDIAC Back to Search Results
Model Number TSCF-35-145-3
Device Problems Material Fragmentation (1261); Difficult to Insert (1316)
Patient Problem Vascular Dissection (3160)
Event Date 05/09/2016
Event Type  Injury  
Event Description
The catheter was inserted into the right common iliac artery and took an incorrect turn down the left common iliac and into a bifurcation.There was some difficulty in pulling back the guide wire and a left groin catheter was inserted to try and retrieve it.When pulling on the catheter, the tip broke off and was unable to retrieved.After injecting contrast into the arteries, there is concern for a small dissection into the wall of the artery.Patient is being transferred to the picu for observation to monitor potential bleeding.Left external iliac artery dissection during guidewire insertion during a heart cath resulting in an ischemic left leg.Vascular surgery was called in to repair the artery.No evidence of compartment syndrome.Pulses returned.
 
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Brand Name
SAFE-T-J GUIDEWIRE .035"
Type of Device
GUIDEWIRE CARDIAC
Manufacturer (Section D)
COOK MEDICAL
750 daniels way
bloomington IN 47402
MDR Report Key5649734
MDR Text Key45001593
Report Number5649734
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2016
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model NumberTSCF-35-145-3
Device Catalogue NumberG00511
Device Lot Number6407585
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/10/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age3 YR
Patient Weight18
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