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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
Catalog Number UNK TREK
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event - estimated. The unique device identifier (udi) is unknown because the part number and lot number were 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 lot number was not provided. The investigation was unable to determine a conclusive cause for the reported complaints. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. The gw referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat an unknown lesion. A 014 hi-torque pilot guide wire (gw) was advanced and positioned. Next, the unspecified abbott balloon dilatation catheter (bdc) was advanced over the pilot gw, towards the target lesion. Once the bdc was next to the target lesion, the guide wire and bdc became stuck together and the bdc could not be advanced further or removed from the guide wire. The unknown abbott bdc and the pilot guide wire were removed from the anatomy as a single unit. Once the devices were removed, the devices became unstuck from each other. A new guide wire and balloon dilatation catheter were used to successfully complete the procedure. There was no reported adverse patient effect or a clinically significant delay in procedure. No additional information was provided.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceDILATATION 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 Key14022600
MDR Text Key288692863
Report Number2024168-2022-03621
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK TREK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
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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