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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 1012455-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the 5. 00x15 mm nc trek balloon failed to deflate during the procedure. The balloon was inflated 2-3 times to 14-16 atmospheres. Negative pressure was held for ¿ages,¿ but the balloon would not deflate. A 50 ml syringe was then used on negative and was able to partially deflate the balloon, which allowed the balloon to be partially pulled into the guiding catheter and removed from the patient without issue. The procedure was completed at this point. There were no reported adverse patient effects and there was no reported 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 Key9983763
MDR Text Key188515675
Report Number2024168-2020-03798
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152153
UDI-Public08717648152153
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-15
Device Catalogue Number1012455-15
Device Lot Number00115G1
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 Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2020
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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