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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 1012278-20
Device Problems Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
Event Type  malfunction  
Event Description
It was reported that during a coronary intervention, the 4. 00 x 20mm trek balloon dilatation catheter was advanced to the lesion. Upon inflation of the balloon, it was noted that inflation was slow before reaching nominal pressure, so the device was attempted to be removed; however, resistance was noted with the 0. 014 guide wire, so both devices were removed as a single unit. Once removed, a leak was observed at the junction with the monorail guiding catheter. There was no reported adverse patient effect and no clinically significant delay in the procedure. Another unspecified device was used to continue the procedure. 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.
 
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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 Key14598510
MDR Text Key293354244
Report Number2024168-2022-05964
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138720
UDI-Public08717648138720
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012278-20
Device Catalogue Number1012278-20
Device Lot Number00713G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2020
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: 06/03/2022 Patient Sequence Number: 1
Treatment
0.014 GUIDE WIRE; MONORAIL GUIDING CATHETER
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