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

[187719819] The device was not returned for analysis. A review of the lot history record and complaint history of the reported lot could not be conducted, because the lot number was not provided. The reported difficulty and subsequent treatment appear to be related to an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to circumstances of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The additional proglide device is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10


[187719820] It was reported as a general comment that an arteriotomy closure of common femoral arteries was attempted using proglide devices with a 7f sheath after interventional low leg procedures. Reportedly, when the plungers were removed, there was no suture for all proglide devices. Manual arterial compression was used to achieve hemostasis. There was no adverse patient sequela and no reported clinically significant delay in the procedures or therapies. The number of patients and procedures was not provided. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03172
MDR Report Key9908253
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-10
Date Mfgr Received2020-03-09
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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