FDA.reportPublic FDA data

MAUDE MDR 9860179

MDR report key
9860179
Report number
2024168-2020-02695
Event key
0
Event type
3
Date of event
2020-02-27
Date received
2020-03-20
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
1STEERABLE GUIDE CATHETERVALVE REPAIRABBOTT VASCULARDRASGC0301SGC030191213U120R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-200

Event Narratives#

N

Patient 1

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

D

Patient 1

THIS IS FILED TO REPORT A LEAK. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE STEERABLE GUIDE CATHETER (SGC) WAS INSERTED BUT WAS UNABLE TO CROSS THE TRANSSEPTAL DUE TO A VERY COMPLIANT SEPTUM. IT WAS NOTED THAT A BALLOON WAS USED ON TWO OCCASION IN AN ATTEMPT TO ADVANCE THE SGC INTO THE LEFT ATRIUM (LA), BUT WAS UNSUCCESSFUL. AFTER THREE PRIOR ATTEMPTS TO CROSS THE SEPTUM, AIR WAS NOTICED DURING THE FOURTH PREPARATION OF THE SGC AS IT WAS NO LONGER HOLDING FLUID COLUMN. THE SGC WAS NOT REENTERED INTO THE PATIENT. IT WAS NOTED THAT NO AIR WAS IN THE DEVICE DURING THE FIRST THREE ATTEMPTS TO CROSS THE SEPTUM. A NEW SGC INSERTED AND WAS ABLE TO CROSS THE SEPTUM AND REACH THE LA. ONE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.