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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK RX TREK
Device Problem Unintended System Motion (1430)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date estimated. The udi is unknown because the part number was not provided. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided. The investigation was unable to determine a conclusive cause for the reported difficulty inflating the balloon (balloon slipping). There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the account is dissatisfied with the performance of the trek balloon catheters. Reportedly, when the balloon reaches the target lesion, the balloon tends to slip from where it is placed. The balloons is "watermelon seeding". There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameTREK RX 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 Key9823484
MDR Text Key183124935
Report Number2024168-2020-02306
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RX TREK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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