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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 1012270-12
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2020
Event Type  malfunction  
Manufacturer Narrative
The device was discarded and will not return. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on the left anterior descending (lad) coronary artery lesion. A mini trek advanced to the lesion site when the operator observed that the markers were not visible. Another device was used in replacement. There were no adverse patient effects and there was no clinically significant delay.
 
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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 Key9924125
MDR Text Key187080446
Report Number2024168-2020-03365
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-12
Device Catalogue Number1012270-12
Device Lot Number90913G2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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