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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER

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AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER Back to Search Results
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Estimated date of occurrence. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during the procedure to treat an unspecified lesion, there was a poor connection between the luer lock syringe and an unknown mini trek balloon dilatation catheter. The connection was leaking while attempting to inject saline/contrast in the catheter lumen. No additional information was provided.
 
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Brand NameMINI TREK II OTW CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8691962
MDR Text Key147753531
Report Number2024168-2019-04625
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received06/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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