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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012448-12
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
Date of event, relevant tests/lab data: estimated date. Exemption number e2019001. The customer reported the device was discarded. Investigation is not yet complete. A follow-up will be submitted with all relevant information.
 
Event Description
It was reported that an unspecified 2. 75x12mm trek balloon dilatation catheter (bdc) was prepped outside the anatomy prior to use, and the contrast mix was omnipaque 300x500. The bdc was inflated to 18 atmospheres; however, it failed to deflate after almost 10 minutes of trying. The balloon was intentionally ruptured using manual inflation with a syringe in order to remove it. There were no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TREK RX
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 Key9512442
MDR Text Key174338064
Report Number2024168-2019-14943
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151811
UDI-Public08717648151811
Combination Product (y/n)N
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,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012448-12
Device Catalogue Number1012448-12
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 Received01/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2019 Patient Sequence Number: 1
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