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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 1012453-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969)
Event Date 07/10/2021
Event Type  malfunction  
Event Description
Patient admitted with cp x few weeks and found to have st-elevated myocardial infarction stemi. The patient was taken to the catheterization lab for angiography and potential percutaneous intervention. During the procedure, coronary balloon, from nc trek coronary dilatation catheter, could not be removed from guide catheter during angioplasty/stent procedure. The body of the balloon telescoped inside itself and made a hard ridge that got stuck on guideliner making it impossible to be removed from guide catheter. As a result, the entire system had to be removed. Additional notes. Drug-eluting stent placed and post-dilated with a 4. 0 x 15 mm nc trek balloon at high pressure. Health care providers were unable to pull the deflated balloon completely back into the guide, so the entire system was removed as one. The balloon then stuck as it was entering the radial sheath. The balloon was advanced over the wire a bit, inflated to very low pressure, and then successfully withdrawn as it was deflated. Inspection of the balloon revealed that the more distal edge that had failed to assume a lower profile.
 
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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 Key12216846
MDR Text Key263138253
Report Number12216846
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 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-15
Device Catalogue Number1012453-15
Device Lot Number10213G1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2021
Event Location Hospital
Date Report to Manufacturer07/23/2021
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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