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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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ABBOTT VASCULAR INC. NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 1012455-20
Device Problems Entrapment of Device (1212); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 07/18/2021
Event Type  malfunction  
Event Description
Upon retrieval of the nc trek coronary dilatation catheter 5. 0 mm x 20 mm / rapid-exchange (post expansion), the device became lodged in the guide catheter. As the doctor tugged a bit harder the balloon separated into two pieces. The doctor removed the entire system (balloon, guide wire and guide catheter) with the balloon remainder stuck in the guide catheter, but subsequently removed.
 
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Brand NameNC TREK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez road
temecula CA 92591
MDR Report Key12404949
MDR Text Key269305811
Report Number12404949
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-20
Device Catalogue Number1012455-20
Device Lot Number0072G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2021
Event Location No Information
Date Report to Manufacturer09/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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