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U.S. Department of Health and Human Services

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

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TREK/ABBOTT VASCULAR CORONARY DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 5.00 MM X 12 MM, 145 CM
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
Balloon separated from catheter. Fda safety report id #: (b)(4).
 
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Brand NameCORONARY DILATATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
TREK/ABBOTT VASCULAR
MDR Report Key10179818
MDR Text Key196201930
Report NumberMW5095132
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 Risk Manager
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model Number5.00 MM X 12 MM, 145 CM
Device Catalogue Number1012280-12
Device Lot Number80615G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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