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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 1012276-20
Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 03/19/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 procedure was to treat a right coronary artery. A 3. 5x20mm trek balloon was not air aspirated outside the anatomy prior to use. The balloon was then advanced to the lesion and inflated twice (first time 16atmospheres (atm) and second time 20atm) without issue. The balloon was held negative for 10 seconds to deflate, however it could only be partially deflated and got stuck in the patient's vessel during pulling back of the device. The distal shaft tore off. Two hours of unsuccessful attempts were made to retrieve the separated portion, when it was decided to transfer the patient to another hospital for surgical intervention. Once at the other hospital, the separated shaft was able to be retrieved via biceps forceps and balloon trapping. Surgical intervention was not required. A clinically significant delay was reported. 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 Key11614595
MDR Text Key243793096
Report Number2024168-2021-02732
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138584
UDI-Public08717648138584
Combination Product (y/n)N
Reporter Country CodeAU
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 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-20
Device Catalogue Number1012276-20
Device Lot Number00717G1
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 Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2020
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: 04/05/2021 Patient Sequence Number: 1
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