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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 1012274-30
Device Problems Unintended System Motion (1430); Difficult to Remove (1528); Material Separation (1562); Failure to Deflate (4060)
Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Event Date 02/02/2022
Event Type  Death  
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 the procedure was to treat an in-stent restenosis in the circumflex coronary artery. The in-stent restenosis was treated with two balloon inflations. While in the circumflex artery, a moderately calcified and moderately tortuous lesion was noted in the left anterior descending (lad) artery with intravascular ultrasound (ivus). A trek rx 3 x 30mm balloon delivery catheter (bdc) was prepped (air aspiration) outside the anatomy and was then inserted and was inflated. Then it was noted there was no flow in the circumflex artery and the patient experienced an increased heart rate and a drop in blood pressure. The physician decided to remove the bdc; however, it was noted the balloon would not deflate and resistance was felt. The balloon shaft was removed and it was observed the balloon had completely dislodged from the shaft and was observed in the left main coronary artery. Shortly after this occurred, the patient coded and then passed away. It was suspected this was caused by the dislodged bdc. No additional information was provided.
 
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 the procedure was to treat an in-stent restenosis in the circumflex coronary artery. The in-stent restenosis was treated with two balloon inflations. While in the circumflex artery, a moderately calcified and moderately tortuous lesion was noted in the left anterior descending (lad) artery with intravascular ultrasound (ivus). A trek rx 3 x 30mm balloon delivery catheter (bdc) was prepped (air aspiration) outside the anatomy and was then inserted and was inflated. Then it was noted there was no flow in the circumflex artery and the patient experienced an increased heart rate and a drop in blood pressure. The physician decided to remove the bdc; however, it was noted the balloon would not deflate and resistance was felt. The balloon shaft was removed and it was observed the balloon had completely dislodged from the shaft and was observed in the left main coronary artery. Shortly after this occurred, the patient coded and then passed away. It was suspected this was caused by the dislodged bdc. 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 Key13581700
MDR Text Key285980571
Report Number2024168-2022-01891
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-30
Device Catalogue Number1012274-30
Device Lot Number10330G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2021
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: 02/22/2022 Patient Sequence Number: 1
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