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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012271-15
Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Separation (1562); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 09/26/2020
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 during unpacking of a trek balloon dilatation catheter it was noted that the hypotube was kinked. The technicians decided to troubleshoot the device and inflated outside the body but the balloon failed to inflate. The device was not used and there was no patient involvement. There were no kinks in the hoop coil or chipboard box noted. Another trek was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Device analysis revealed the hypotube was separated, there was a tear in the outer member, and a leak coming out of the tear.
 
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Brand NameTREK 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 Key10731031
MDR Text Key213007004
Report Number2024168-2020-08885
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
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 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012271-15
Device Catalogue Number1012271-15
Device Lot Number91204G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2019
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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