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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012274-20
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/04/2019
Event Type  Injury  
Event Description
Cath lab pt for attempted balloon dilation of lesion. Upon attempting to withdraw deflated balloon, a fragment of the balloon sheared off from the device. Unable to retrieve in cath lab. Fragment retrieved during cagb procedure.
 
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Brand NameABBOTT VASCULAR
Type of DeviceTREK CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside dr.
santa clara CA 95054
MDR Report Key9404828
MDR Text Key169030067
Report Number9404828
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number90719G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2019
Distributor Facility Aware Date11/04/2019
Event Location Hospital
Date Report to Manufacturer11/15/2019
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/18/2019 Patient Sequence Number: 1
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