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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number 101245-08
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2019
Event Type  malfunction  
Event Description
The physician was performing an angioplasty of the diagonal branch of the left anterior descending artery (lad). The surgeon was attempting to open up the artery with a balloon at high pressures after attempting to open with an atherectomy. During the inflation of the nc trek, the physician inflated the balloon up to 30 psi (rate burst is 18 psi). The balloon burst. When the balloon was removed it was inspected and discovered that the tip had completely broken off. The md and tech looked but were unable to locate it. They suspected the tip may have remained in the body. The patient showed no signs or symptoms of discomfort or distress and blood flow in the artery was maintained.
 
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Brand NameNC TREK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591
MDR Report Key9278493
MDR Text Key165089976
Report Number9278493
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 10/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number101245-08
Device Lot Number90726G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/19/2019
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer11/05/2019
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

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