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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 1012272-20
Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Patient Problem Pain (1994)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device location was not provided, and it is unknown if the device is returning for analysis. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat an unspecified lesion. A 2. 5x20mm trek balloon was not prepped (air aspiration) outside the anatomy prior to use. The balloon was advanced and inflated at nominal pressure at the lesion. Deflation for the balloon was noted as difficult but was ultimately able to be deflated. Patient experienced pain when the balloon was dilated. There were no adverse patient effects and no clinically significant delay. No additional information was provided.
 
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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 Key10748796
MDR Text Key213467456
Report Number2024168-2020-08967
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
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 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012272-20
Device Catalogue Number1012272-20
Device Lot Number00424G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
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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