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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012280-12
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Patient Problem Intimal Dissection (1333)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the left main coronary artery common trunk. A 5x12mm trek balloon dilatation catheter (bdc) failed to deflate. The bdc was pulled, and a dissection was noted. The bdc broke [separated] and remained stuck on an unspecified guide wire. The patient then had a bypass surgery. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameTREK RX
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 Key10693116
MDR Text Key211848491
Report Number2024168-2020-08668
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIT
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012280-12
Device Catalogue Number1012280-12
Device Lot Number91018G1
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 Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2019
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: 10/16/2020 Patient Sequence Number: 1
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