PROGLIDE 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 2020-03-30 for PROGLIDE 12673-05 manufactured by Abbott Vascular.

Event Text Entries

[188561313] The other proglide is filed under a separate medwatch report number. The device is expected to be returned for investigation. 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


[188561314] It was reported that suture placement in the calcified common femoral artery was attempted with two proglide devices, using the pre-close technique, via a 6f sheath prior to a transcatheter aortic valve implantation (tavi) procedure. Reportedly, the plunger was? Retracted and comes out heavily?. Resistance is felt while harvesting the suture and the suture was ruptured or lost. Another proglide was successfully preplaced. A new proglide device was used and the plunger was? Retracted and comes out heavily?. Resistance is felt while harvesting the suture and the suture was ruptured or lost. A new proglide was successfully preplaced. The tavi procedure was completed and hemostasis was achieved with the successfully preplaced sutures of two proglide devices. There was no reported adverse patient sequela or 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 Number2024168-2020-03120
MDR Report Key9901374
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-02-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-12-06
Date Added to Maude2020-03-30
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 Received2020-03-30
Catalog Number12673-05
Lot Number9120641
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 2020-03-30

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