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 2017-03-13 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[70092763] We have received and evaluated the complaint device. We were able to confirm the reported incident. We found that one of the blade did not insert into the retainer when the centering hoops were closed. We also found that it was the same blade that did not close into the retainer when the centering hoops were opened and closed multiple time. After we manually fixed the blade using a forceps, the blade inserted into the retainer and was able to close completely. No issue was noted when the centering hoop was opened and closed multiple times after fixing this defect. Our lot history records review did not reveal any discrepancies related to the complaint event either in the manufacturing or packaging processes. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. However, it is possible that one of the blades was damaged (over tweaked) during the manufacturing process. The blade tweaking process includes manual adjustment of each blade by the operator. Operator errors, though rare, are possible due to the manual nature of the adjustments. We have initiated a corrective action to investigate this issue. The corrective action includes use of new fixtures, evaluation of current fixtures in place and addition of preventive maintenance for the fixtures.
Patient Sequence No: 1, Text Type: N, H10


[70092764] During pre-use check, the blades of the valvulotome did not close.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2017-00023
MDR Report Key6401288
Date Received2017-03-13
Date of Report2017-03-13
Date of Event2017-02-13
Date Mfgr Received2017-02-13
Device Manufacturer Date2015-05-22
Date Added to Maude2017-03-13
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 Received2017-03-13
Returned To Mfg2017-03-10
Catalog Number1009-00
Lot NumberELVH1058V
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-13

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