PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM 12673-03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM 12673-03 manufactured by Abbott Vascular.

Event Text Entries

[189057304] The device will not be returned as it was discarded. Investigation has not yet begun. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10


[189057305] It was reported that suture placement in a common femoral vein was attempted with a proglide device using the pre-close technique via a 6f sheath prior to a percutaneous valve repair interventional procedure. Reportedly, there was no suture present when the plunger was removed. The sutures of two new proglide devices were successfully pre-placed. The sheath was upsized to a 14f and the percutaneous valve repair procedure was completed. Hemostasis was achieved with the pre-placed proglide sutures. There was no reported adverse patient sequela and no reported clinically significant delay in the procedure or therapy. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03181
MDR Report Key9908512
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-21
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005718570
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL TIPPERARY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Generic NameSUTURE MEDIATED CLOSURE
Product CodeMGB
Date Received2020-03-31
Model Number12673-03
Catalog Number12673-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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