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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 1012269-12
Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. Visual and functional inspections were performed on the returned device. The reported loose or intermittent connection was not confirmed. However, a proxy indeflator, filled with water, was used to pressurize the balloon when fluid leaked out of the noted crack at the proximal end of the hub. In this case, it is possible that the inflation device was over torqued during attempts to connect to the hub of the device, resulting in the noted cracks, chipped off threading of the luer, leak and subsequently the reported loose or intermittent connection. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. The investigation determined the reported difficulty appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
 
Event Description
It was reported that a 1. 50x12mm mini trek rx balloon dilatation catheter (bdc) was not able to connect properly to an indeflator. The bdc was not used. The procedure was successfully completed with an unspecified bdc. There was no patient involvement and there was no clinically significant delay in the procedure. The return device analysis identified that a portion of the threading on the luer was chipped off and that there was a leak at the noted crack on the hub. 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 Key9507094
MDR Text Key178334257
Report Number2024168-2019-14873
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138096
UDI-Public08717648138096
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number1012269-12
Device Lot Number90713G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2019
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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