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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012268-06U
Device Problems Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/26/2020
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. (b)(4).
 
Event Description
It was reported the procedure was to treat a lesion in the left main (lm) artery. The 1. 20x6mm rx mini trek balloon dilatation catheter (bdc) was advanced to the lesion and the balloon inflated three times to 20, 15, and 15 atmospheres (atm) respectively when the balloon ruptured. The device was removed however it was noted the shaft had separated, the distal 10cm of the device remained in the anatomy. Attempts to retrieve the separated portion were unsuccessful and the device remains in the anatomy. The patient was transferred to the intensive care unit (icu) to be further monitored. No additional information was provided.
 
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Brand NameMINI TREK 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 Key9823562
MDR Text Key184758712
Report Number2024168-2020-02311
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012268-06U
Device Catalogue Number1012268-06U
Device Lot Number90731G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2019
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: 03/12/2020 Patient Sequence Number: 1
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