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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 1012273-12
Device Problem Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2020
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. Na.
 
Event Description
It was reported that during unpacking of a 2. 75x12mm trek balloon dilatation catheter (bdc), the connection piece of the hub was found to be broken off. The device was not used and there was no patient involvement. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key10244787
MDR Text Key197975279
Report Number2024168-2020-05544
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138355
UDI-Public08717648138355
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103110
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 08/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2022
Device Model Number1012273-12
Device Catalogue Number1012273-12
Device Lot Number91002G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2019
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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