PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM 12673-05

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM 12673-05 manufactured by Abbott Vascular.

Event Text Entries

[189057927] 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.
Patient Sequence No: 1, Text Type: N, H10


[189057928] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03180
MDR Report Key9908491
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2018-12-05
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
Catalog Number12673-05
Lot Number8120541
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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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