MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR manufactured by Abbott Vascular.

Event Text Entries

[186380491] The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10


[186380492] This is filed for leak. It was reported that the clip delivery system (cds) packaging was opened and it was noted that the red cap was off and loose in the box. The device was prepped and it was noted to be leaking at the "o" ring on the lock lever. No troubleshooting was performed, as the physician was uncomfortable using the device. There was no patient involvement and no clinically significant delay in procedure. No additional information was provided regarding this issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03177
MDR Report Key9908393
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-10-17
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005070406
Manufacturer Street3885 BOHANNON DRIVE
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal Code94025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMITRACLIP? SYSTEM CLIP DELIVERY SYSTEM
Generic NameVALVE REPAIR
Product CodeNKM
Date Received2020-03-31
Returned To Mfg2020-03-25
Model NumberCDS0601-XTR
Catalog NumberCDS0601-XTR
Lot Number91017U160
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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