PROGLIDE 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 PROGLIDE 12673-03 manufactured by Abbott Vascular.

Event Text Entries

[188868005] The other additional proglide is being filed under a separate medwatch report number. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Based on the information reviewed, 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. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10


[188868006] It was reported that arteriotomy closure of a calcified common femoral artery was attempted using two proglide devices after an interventional angiogram procedure. Reportedly, when the plunger was removed, no sutures were attached, with both proglide devices. Another closure device was used to achieve hemostasis. There was no reported adverse patient sequela. There was no reported clinically significant delay in the entire procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03169
MDR Report Key9908189
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-18
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-12-11
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 NamePROGLIDE
Generic NameSUTURE MEDIATED CLOSURE
Product CodeMGB
Date Received2020-03-31
Model Number12673-03
Catalog Number12673-03
Lot Number9121141
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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