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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX 3.5 MM X 15 MM ANGIOPLASTY BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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ABBOTT VASCULAR TREK RX 3.5 MM X 15 MM ANGIOPLASTY BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number TREK RX BALLOON
Device Problem Deflation Problem (1149)
Patient Problem Insufficient Information (4580)
Event Date 10/11/2021
Event Type  malfunction  
Event Description
Angioplast balloon inflated in coronary artery and would not deflated with multiple stents. Fda safety report id# (b)(4).
 
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Brand NameTREK RX 3.5 MM X 15 MM ANGIOPLASTY BALLOON
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key12638690
MDR Text Key276881831
Report NumberMW5104638
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTREK RX BALLOON
Device Catalogue Number1012276-15
Device Lot Number01104G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Is the Reporter a Health Professional? Yes
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

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
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