FDA.reportPublic FDA data

MAUDE MDR 9862900

MDR report key
9862900
Report number
2024168-2020-02762
Event key
0
Event type
3
Date of event
2020-03-02
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 VASCULARDRASGC030291118U134N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. R

Event Narratives#

N

Patient 1

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

D

Patient 1

THIS IS BEING FILED TO REPORT LEAK, CRACK, AND MEDICAL INTERVENTION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. IT WAS NOTED SUB-OPTIMAL TRANSSEPTAL PUNCTURE. THE FIRST CLIP WAS SUCCESSFULLY DEPLOYED. THEN WHEN ADVANCING THE SECOND CLIP DELIVERY SYSTEM (CDS) INTO THE STEERABLE GUIDE CATHETER (SGC), LOSS OF FLUID COLUMN WAS OBSERVED AND AIR ENTERED THE OUTSIDE PART OF THE SGC. ADDITIONAL ASPIRATIONS WERE PERFORMED AND BOTH THE CDS AND SGC WERE REMOVED FROM THE PATIENT. THE DEVICES WERE INSPECTED AND IT WAS OBSERVED THAT THE HEMOSTATIC VALVE OF THE SGC WAS CRACKED WHICH RESULTED IN AIR LEAKAGE, AND THE CLIP WOULD NOT OPEN. THEREFORE, THE PROCEDURE CONTINUED WITH A NEW SGC AND A NEW CDS. TWO CLIPS WERE IMPLANTED, REDUCING MR TO 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.