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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 1012272-15
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2017
Event Type  malfunction  
Event Description
Upon doctors order to inflate the balloon to nominal pressure, the contrast used to fill and visually see the balloon upon inflation, was seen escaping the balloon and going distally in the lad. Doctor ordered the balloon be placed in a negative pressure with the hand deflator. No harm to patient.
 
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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 Key7032538
MDR Text Key92066474
Report Number7032538
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 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012272-15
Device Catalogue Number1012272-15
Device Lot Number70826G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2017
Event Location Other
Date Report to Manufacturer11/08/2017
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

Patient Treatment Data
Date Received: 11/15/2017 Patient Sequence Number: 1
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