FDA.reportPublic FDA data

MAUDE MDR 9908592

MDR report key
9908592
Report number
2024168-2020-03184
Event key
0
Event type
3
Date of event
2020-03-09
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
1PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEMSUTURE MEDIATED CLOSUREABBOTT VASCULARMGB12673-0312673-038092841N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED; HOWEVER, INVESTIGATION HAS NOT YET BEGUN. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

D

Patient 1

IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO AN AORTA STENT INTERVENTIONAL PROCEDURE. THE SUTURES OF TWO PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 14F AND THE AORTA STENT INTERVENTIONAL PROCEDURE WAS COMPLETED. REPORTEDLY, AT TIME OF CLOSURE, A SUTURE BREAK OCCURRED WITH THE SUTURES OF THE SECOND DEVICE PRE-PLACED. WIRE ACCESS REMAINED AND A THIRD DEVICE WAS DEPLOYED; HOWEVER, AT THE TIME TO REMOVE THE DEVICE, IT BECAME STUCK SURGERY WAS PERFORMED TO REMOVE THE DEVICE. IT WAS NOTICED THE DEVICE WAS BROKEN BUT STILL HELD TOGETHER BY THE ACTUATOR WIRE. HEMOSTASIS WAS ACHIEVED VIA SURGICAL SUTURING. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WILL BE PROVIDED.