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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 1012447-12
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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. It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use states: complete the following steps to prepare the nc trek rx coronary dilatation catheter for use: slide the protective sheath off the balloon prior to performing air aspiration. In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint. The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. Na.
 
Event Description
It was reported that during preparation of a 2. 50x12mm nc trek balloon, the yellow cover (protective sheath) was stuck firmly to the balloon and was unable to be removed. Another nc trek was used to successfully complete the procedure. It was confirmed that the first nc trek was flushed per the instructions for use prior to attempted removal of the protective sheath. 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 Key11144316
MDR Text Key226092232
Report Number2024168-2021-00279
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIR
PMA/PMN Number
K103153
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 01/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012447-12
Device Catalogue Number1012447-12
Device Lot Number90921G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2019
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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