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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 1012455-12
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2022
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a mildly calcified, heavily tortuous, 80% re-stenosed stent in the right coronary artery (rca). A 5x12mm nc trek balloon dilatation catheter (bdc) was used to dilatate the lesion, however during removal, the balloon shaft separated into two pieces and the separated piece remained in the sheath. A guide wire with an unspecified armada balloon, were used to pin the separated piece of the balloon and pull it out of the tip of the sheath to remove it while maintaining access with the sheath. The procedure was concluded at that point. There was no adverse patient effect 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 Key14952050
MDR Text Key295472445
Report Number2024168-2022-07349
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-12
Device Catalogue Number1012455-12
Device Lot Number20215G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2022
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: 07/07/2022 Patient Sequence Number: 1
Treatment
ARMADA BALLOON
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