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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012447-15
Device Problems Leak/Splash (1354); Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned for analysis. The reported hub separation was unable to be confirmed however there was a noted hypotube separation. 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 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 inadvertent mishandling during preparation for use resulted in the noted hypotube separation/reported hub separation; thus resulting in the reported leak. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that an attempt to air aspirate a 2. 5x15mm nc trek balloon dilatation catheter (bdc) with a syringe was made; however, it was not possible because air was coming in the syringe. Additionally, the hub separated from the shaft. The procedure was successfully completed with a new 2. 5x15mm nc trek bdc and the deployment of an unspecified drug eluting stent. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TREK 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 Key10335708
MDR Text Key200811384
Report Number2024168-2020-06265
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151767
UDI-Public08717648151767
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Model Number1012447-15
Device Catalogue Number1012447-15
Device Lot Number91128G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2019
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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