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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR INC. TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 1012272-12
Device Problem Burst Container or Vessel (1074)
Patient Problems Exposure to Body Fluids (1745); Rupture (2208)
Event Date 04/18/2018
Event Type  malfunction  
Event Description
A 2. 5 x 12 trek coronary balloon burst in body after the second inflation.
 
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Brand NameTREK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez rd.
temecula CA 92591
MDR Report Key7494035
MDR Text Key107586824
Report Number7494035
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 04/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012272-12
Device Catalogue Number1012272-12
Device Lot Number80130G1
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 FDA04/23/2018
Event Location Hospital
Date Report to Manufacturer04/23/2018
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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