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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 1012454-08
Device Problems Failure to Fold (1255); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
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.
 
Event Description
It was reported that the procedure was performed to treat a lesion with heavy calcification and moderate tortuosity in right coronary artery (rca). The 4. 50 x 8 mm nc trek balloon catheter was advanced to the target lesion without issue and inflated to nominal pressure. During removal of the balloon catheter, there was resistance with guiding catheter. Both devices were removed as one single unit from the patient anatomy. Outside the anatomy, it was noted that the distal end of the balloon was distorted [damaged]. 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 Key12315285
MDR Text Key266306363
Report Number2024168-2021-07120
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 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012454-08
Device Catalogue Number1012454-08
Device Lot Number00618G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
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: 08/12/2021 Patient Sequence Number: 1
Treatment
GUIDING CATHETER
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