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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012270-15
Device Problem Inflation Problem (1310)
Patient Problem No Code Available (3191)
Event Date 07/19/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional devices referenced are filed under separate medwatch report numbers.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery. The following balloon dilatation catheters (bdc) (3x15mm nc trek, 3x15mm trek, and 2x15mm mini trek) were used in the patient in the same procedure. All three bdcs failed to inflate, and there was an unknown serious injury that may be related to the devices. An unspecified stent was used to successfully complete the procedure. Reportedly, there was no adverse patient sequelae and no reported clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMINI 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 Key11132223
MDR Text Key225555000
Report Number2024168-2021-00205
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K103110
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 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-15
Device Catalogue Number1012270-15
Device Lot Number91007G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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