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

[187717784] 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.
Patient Sequence No: 1, Text Type: N, H10


[187717785] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03184
MDR Report Key9908592
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Device Manufacturer Date2018-09-28
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 (P099)
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
Returned To Mfg2020-03-25
Model Number12673-03
Catalog Number12673-03
Lot Number8092841
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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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