FDA.reportPublic FDA data

MAUDE MDR 9908491

MDR report key
9908491
Report number
2024168-2020-03180
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 VASCULARMGB12673-058120541R Y

Patients#

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

Event Narratives#

N

Patient 1

THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

D

Patient 1

IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 7F SHEATH AFTER A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. REPORTEDLY, WHEN ATTEMPTING TO DEPRESS THE PLUNGER, THE PLUNGER RETURNED IT ITS ORIGINAL POSITION. IT WAS DEPRESSED AGAIN BUT SAME ISSUE OCCURRED. A THIRD ATTEMPT WAS MADE BUT SAME ISSUE OCCURRED. THE DEVICE WAS REMOVED, AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.