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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR COSTA RICA NC-TREK 4.5 X 12 BALLOON CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY

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ABBOTT VASCULAR COSTA RICA NC-TREK 4.5 X 12 BALLOON CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY Back to Search Results
Catalog Number 1012454-12
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2019
Event Type  malfunction  
Event Description
After deflation of the balloon, the balloon was unable to be pulled back into the guide catheter.
 
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Brand NameNC-TREK 4.5 X 12 BALLOON
Type of DeviceCATHETER TRANSLUMINAL CORONARY ANGIOPLASTY
Manufacturer (Section D)
ABBOTT VASCULAR COSTA RICA
CS
MDR Report Key8624806
MDR Text Key145754283
Report NumberMW5086766
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1012454-12
Device Lot Number80810G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 05/17/2019 Patient Sequence Number: 1
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