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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number 1012272-15
Device Problem Material Rupture (1546)
Patient Problems Chest Pain (1776); Pain (1994)
Event Date 01/13/2017
Event Type  malfunction  
Event Description
Physician inflated a 2. 0x15 trek balloon to 18atm. Balloon ruptured. Patient shortly after this, complained of 10/10 chest and jaw pain. Pain meds and vasodilator were given per physician and pain diminished slowly over the next 15 years.
 
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Brand NameNC TREK RX CORONARY DILATATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside drive
santa clara CA 95054
MDR Report Key6275617
MDR Text Key65692077
Report Number6275617
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
Type of Report Initial
Report Date 01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number1012272-15
Device Lot Number61102G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2017
Event Location Hospital
Date Report to Manufacturer01/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/25/2017 Patient Sequence Number: 1
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