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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 1012453-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. Na.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the non-calcified, non-tortuous proximal left anterior descending coronary artery. After an unspecified stent was implanted, a 4x15mm trek balloon dilatation catheter (bdc) was advanced, but the balloon only partially deflated. The bdc was unable to be removed due to resistance with an unspecified guide wire and unspecified guiding catheter, so the system was removed together as one unit to successfully complete the procedure. 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 Key11694483
MDR Text Key246696469
Report Number2024168-2021-03304
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-15
Device Catalogue Number1012453-15
Device Lot Number91227G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2019
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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