FDA.reportPublic FDA data

MAUDE MDR 9908393

MDR report key
9908393
Report number
2024168-2020-03177
Event key
0
Event type
3
Date of event
2020-03-10
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDSEY BELL
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MITRACLIP? SYSTEM CLIP DELIVERY SYSTEMVALVE REPAIRABBOTT VASCULARNKMCDS0601-XTRCDS0601-XTR91017U160N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

D

Patient 1

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.