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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 1012274-20
Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problems Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Event Date 10/19/2021
Event Type  Injury  
Event Description
It was reported that the patient presented with chest pain and restenosis. The procedure was to treat a heavily calcified vessel in the proximal circumflex artery and the 3. 0x20mm nc trek balloon dilatation catheter (bdc) was used for pre-dilatation. Resistance was felt due to the heavily calcified lesion and the bdc was inflated once with a pressure of 20 atmospheres (atms). At this point the physician did not know that upon removal, the balloon had detached from the delivery system. Moderate force had been applied due to the nature of the calcium in the anatomy. Another stent was placed and the balloon markers were noted on check imaging. The balloon had moved to the distal circumflex. The distal circumflex artery had no blood flow for a short time, however, the patient remained stable throughout. Snare was considered but not attempted due to the small vessel. A medtronic stent was used to embed the balloon in the healthy tissue of the distal circumflex. There was no reported significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
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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 Key12782556
MDR Text Key280763726
Report Number2024168-2021-10183
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number10318G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2021
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: 11/09/2021 Patient Sequence Number: 1
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