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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported the device was discarded and is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This report is filed as the steerable guide catheter was unable to hold fluid column during preparation. It was reported that the steerable guide catheter was being prepped per instructions for use when the fluid column was unable to hold. There were no other device issues observed, however, after 4 attempts testing the fluid column, the fluid column was unable to hold. There was no patient involvement and the device was discarded. No additional information was provided regarding this device issue.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10928026
MDR Text Key218958160
Report Number2024168-2020-10025
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
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 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/16/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00616U142
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 Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2020
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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