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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 1012455-20
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
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 popliteal artery. During the procedure, the 5. 00x20 mm nc trek balloon dilatation catheter (bdc) had problems with deflation and could only partially deflate. The bdc was inflated to 16 atmospheres three times and negative pressure was held for 1 minute. The bdc was removed partially inflated. An unspecified stent was used to complete the procedure. There were no reported 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 Key11319151
MDR Text Key234435247
Report Number2024168-2021-01140
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152160
UDI-Public08717648152160
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 06/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-20
Device Catalogue Number1012455-20
Device Lot Number00109G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2020
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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