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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 1012276-08
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Event Date 01/16/2021
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet completed. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the patient presented in stable condition after experiencing an acute myocardial infarction, but percutaneous intervention (pci) was determined to be urgent. After successful stent implantation in the left circumflex coronary artery, a 3. 5x8mm trek balloon was advanced for stent post-dilatation, but the balloon failed to inflate during the first inflation. At that point, electrocardiogram (ecg) changes were noted, the patient became seriously hypotensive and went into cardiac arrest. Air was noted in all branches of the left coronary and a hole was noted on the shaft of the trek catheter. Advance cardiopulmonary resuscitation was initiated, including intubation, medications and cardiac compressions. After 15 minutes, the patient recovered and after 2 days, the patient was extubated, with no adverse sequela. 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 Key11298776
MDR Text Key230930233
Report Number2024168-2021-00999
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138553
UDI-Public08717648138553
Combination Product (y/n)N
Reporter Country CodeFR
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 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-08
Device Catalogue Number1012276-08
Device Lot Number91206G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2019
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: 02/08/2021 Patient Sequence Number: 1
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