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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 1012451-12
Device Problems Inflation Problem (1310); Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Visual and functional inspections were performed on the returned device which determined the hypotube was separated. Follow-up was performed with the site; however, they were unaware of when the separation occurred. The reported inflation issue was not confirmed. The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances. 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 advancing the device appears to be related to operational context; however, a conclusive cause for the reported inflation issue could not be determined. 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 the procedure was performed to treat a moderately tortuous and moderately calcified de novo lesion in the left anterior descending artery. A 3. 5x12mm nc trek rx balloon dilatation catheter (bdc) was advanced to the target lesion; however, resistance with the anatomy was felt and the balloon only partially inflated. The procedure was successfully completed with an unspecified nc trek rx bdc. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned device analysis identified a separated hypotube. Follow-up was performed; however, the account was not aware of the separation.
 
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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 Key12665918
MDR Text Key277424054
Report Number2024168-2021-09413
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeEG
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 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012451-12
Device Catalogue Number1012451-12
Device Lot Number90905G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2019
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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