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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 1012447-06
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
It was reported that following prepping and flushing the device, the yellow protective sheath of the 2. 5x6. 0mm nc trek balloon dilatation catheter (bdc) could not be removed. The device was not used and there was no patient involvement. A 2. 50x15mm nc trek bdc was used to complete the procedure. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. (b)(4).
 
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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 Key12781290
MDR Text Key284382701
Report Number2024168-2021-10177
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K103153
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,Followup
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012447-06
Device Catalogue Number1012447-06
Device Lot Number90628G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2019
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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