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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012403-06A
Device Problems Unintended System Motion (1430); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)
Event Date 08/06/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that a 2x6mm mini trek ii balloon dilatation catheter (bdc) moved unintentionally twice, and a marker separated from the device. The marker remains in the patient anatomy, and the vein became damaged [dissection], which interfered during contrast media administration. An unspecified balloon was used to successfully complete the procedure. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMINI TREK II OTW CORONARY DILATATION CATHETER
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 Key12392978
MDR Text Key268971822
Report Number2024168-2021-07694
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 Pharmacist
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012403-06A
Device Catalogue Number1012403-06A
Device Lot Number10216G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2021
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: 08/31/2021 Patient Sequence Number: 1
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