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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 1012454-15
Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
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 procedure was to treat the proximal right coronary artery (rca) with mild tortuosity and mild calcification. A radial approach was used. The lesion was pre-dilated with a 3. 5x15 mm trek balloon dilatation catheter (bdc) and then a 4. 0x23 mm xience sierra stent was implanted successfully. A 4. 5x15 mm nc trek bdc was used to post-dilate at 12 atmospheres (atm) twice and then 16 atm in the final inflation. When deflating the nc trek bdc, it was noted the deflation was slow. The deflation time was not recorded and the balloon ultimately partially deflated. An attempt was made to pull the balloon out and it was found that the nc trek bdc was stuck at the tip of the guiding catheter. The bdc could not be removed independently, so it was removed with the guiding catheter with the sheath. Inspection outside the anatomy identified that the distal tip of the balloon had flared and caused the balloon to be stuck at the tip of the guiding catheter. A left radial access was used for a final shot of the procedure. There were no 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 Key12242966
MDR Text Key264082683
Report Number2024168-2021-06624
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMY
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 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012454-15
Device Catalogue Number1012454-15
Device Lot Number00116G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2020
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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