HYDRO LEMAITRE VALVULOTOME 1009-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[134733770] We have not received the complaint device for evaluation since the device has been discarded by the hospital. Hence, we could not conclusively determine the root cause of the defect. Our lot history records review for this lot number did not reveal any discrepancies either in the manufacturing or packaging processes that could be related to this incident. We have not received any other complaints related to a similar issue for devices from this lot number. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. Our quality group also samples these device before final packaging to ensure proper blade adjustment. It is possible that the blade was damaged during packaging or during shipping the device to the hospital. Our ifu clearly informs users to inspect the blades for damage and alignment prior to use. In this case, the user properly followed the risk mitigation measures (ifu) and properly identified the issue. Device was not used in the patient. Another valvulotome was used for the surgery.
Patient Sequence No: 1, Text Type: N, H10


[134733771] One of the four cutting blades of the valvulotome did not close properly into its housing. The malfunction was detected by the surgeon during pre-use check. So, the defective device was replaced with a new valvulotome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2019-00005
MDR Report Key8254720
Date Received2019-01-16
Date of Report2019-01-16
Date of Event2018-12-17
Date Mfgr Received2018-12-17
Device Manufacturer Date2018-06-28
Date Added to Maude2019-01-16
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 ContactMR. PRAGYA THIKEY
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7812212266
Manufacturer G1LEMAITRE VASCULAR, INC.
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal Code01803
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHYDRO LEMAITRE VALVULOTOME
Generic NameVALVULOTOME
Product CodeMGZ
Date Received2019-01-16
Catalog Number1009-00
Lot NumberELVH1477VA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-16

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