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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012268-12U
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 06/29/2020
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 1. 20x12mm mini trek pouch was creased and the device sterility was compromised. There was no damage to the chipboard box. There was no patient involvement. No additional information was provided.
 
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Brand NameTREK RX
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 Key10273131
MDR Text Key200683110
Report Number2024168-2020-05805
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648176555
UDI-Public08717648176555
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2022
Device Model Number1012268-12U
Device Catalogue Number1012268-12U
Device Lot Number91023G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
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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