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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 1012272-15
Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
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. Na.
 
Event Description
It was reported that the procedure was to treat an unspecified lesion. A 2. 5x15mm trek balloon was passing up the radial access when it became stuck. As the device was close to the site of insertion, the device was able to be simply removed and once removed, it was noted the balloon broke at the mid-shaft. The account confirmed that nothing remained in the patient. Another balloon was used to successfully complete the procedure. There was no adverse patient sequela and no clinically significant delay. 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 Key12779303
MDR Text Key280540482
Report Number2024168-2021-10151
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
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 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012272-15
Device Catalogue Number1012272-15
Device Lot Number00303G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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