FDA.reportPublic FDA data

MAUDE MDR 9793535

MDR report key
9793535
Report number
2024168-2020-02038
Event key
0
Event type
3
Date of event
2020-02-12
Date received
2020-03-05
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 VASCULARDRASGC030291119U126R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-050

Event Narratives#

N

Patient 1

THE ADDITIONAL MITRACLIP DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION PROVIDED A CONCLUSIVE CAUSE FOR THE REPORTED LOSS OF FLUID COLUMN CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

D

Patient 1

THIS IS BEING FILED TO REPORT THE LEAK IN THE STEERABLE GUIDE CATHETER (SGC). IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. WHEN INTRODUCING THE CLIP DELIVERY SYSTEM (CDS) INTO THE STEERABLE GUIDE CATHETER (SGC), AIR WAS NOTED. THE CDS WAS REMOVED HOWEVER BECAME STUCK IN THE CLIP INTRODUCER (CI). THE HEMOSTASIS VALVE OF THE SGC WAS NO LONGER SEALED THEREFORE BOTH DEVICES WERE REMOVED AND REPLACED WITH NEW ONES. TWO CLIPS WERE IMPLANTED, REDUCING MR TO 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.