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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR RX MINI TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR RX MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012270-12
Device Problems Inflation Problem (1310); Material Rupture (1546); Difficult to Advance (2920)
Patient Problems Air Embolism (1697); Pain (1994)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the 2. 00x12 mm mini trek balloon dilatation catheter (bdc) had resistance while being advanced on the guide wire. The bdc failed to inflate after one attempt and reportedly, air bubbles were seen in the vessel [indicating a potential balloon rupture]. The bdc was removed and a non-abbott bdc was used to complete the procedure. There was no treatment for the air embolism and it was stabilized. The patient experienced pain due to the embolism. There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameRX MINI TREK
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9833504
MDR Text Key186563131
Report Number2024168-2020-02448
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-12
Device Catalogue Number1012270-12
Device Lot Number91106G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2020 Patient Sequence Number: 1
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