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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012274-20
Device Problems Off-Label Use (1494); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2020
Event Type  malfunction  
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.
 
Event Description
It was reported that the trek rx dilatation catheter was prepped per instructions for use (ifu) without issue. There was no difficulty removing the proactive sheath. The device advanced to the left anterior tibial, moderately calcified lesion without unusual resistance. Upon initial inflation at 6 atmospheres, the balloon burst. Device aspirated was performed and the device was removed without further issues. Reportedly, the aspiration was not performed as a precaution and there was no air embolus. Another trek was successfully used in replacement. There were no adverse patient effects and there was no clinically significant delay. No additional information was provided regarding this issue.
 
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Brand NameTREK 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 Key10856573
MDR Text Key217128524
Report Number2024168-2020-09633
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 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number00110G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2020
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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