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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 1012271-08
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned for analysis. The reported inflation problem was able to be confirmed. 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 incidents from this lot. As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with other devices and/or inadvertent mishandling resulted in the noted longitudinal tear on the outer member; thus resulting in the reported inflation problem/noted leak. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a lesion in the diagonal coronary artery with moderate tortuosity and moderate calcification. The nc trek balloon crossed the lesion; however, during an attempt to inflate the balloon, the pressure did not increase. The balloon catheter was removed without issue. A non-abbott balloon was then used for dilatation. There were no adverse patient effects and no clinically significant delay in the procedure. Return device analysis identified fluid coming from a longitudinal tear on the outer member at the location of the outer member to hypotube seal. 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 Key10969948
MDR Text Key220686829
Report Number2024168-2020-10293
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 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012271-08
Device Catalogue Number1012271-08
Device Lot Number00527G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2020
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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