LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER e1651-84 E1651-84

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 2020-03-11 for LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER e1651-84 E1651-84 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[188687695] We have not received the complaint device for evaluation. Hence, we could not conclusively determine the root cause of the failure. During the follow-up with the contact person at the hospital, we learned that the failure occurred when pulling the arterial plug back into the venous side of the graft. Based on our investigations for similar incidents, it is possible that the balloon was not tied sufficiently to the catheter. It is also possible that some anatomical (calcification or stenosis in the lesion area) or procedural factors (use of excessive force to remove the thrombus) may have contributed to the balloon failure. Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque or overinflated balloon. The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material (eg. Chronic clot, atherosclerotic plaque). This catheter is not designed to withstand the additional pull force needed to remove these materials. Based on this incident and similar incidents reported by other users, we are preparing to initiate a recall on certain lots of lemaitre 5 french plus over-the-wire embolectomy catheters. The scope of the recall is currently being evaluated. There was no injury to the patient as the result of this incident. This is report# 1 of 5. Please note that we have also reported manufacturer's incident report# 1220948-2020-00027, 1220948-2020-00028, 1220948-2020-00030 and 1220948-2020-00031 relating to other 4 similar incidents that was reported to us by the same contact person at the hospital.
Patient Sequence No: 1, Text Type: N, H10


[188687696] During a thrombectomy procedure, the balloon of an over-the-wire embolectomy catheter failed to deflate after pulling the arterial plug into the graft. So, the surgeon punctured the balloon and removed the catheter from the patient's vessel. There was no injury to the patient as the result of this incident. This is report 3 of 5.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2020-00029
MDR Report Key9817823
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-11
Date of Report2020-03-10
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PRAGYA THIKEY
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON, MA
Manufacturer CountryUS
Manufacturer Phone2212266152
Manufacturer G1LEMAITRE VASCULAR, INC.
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON, MA
Manufacturer CountryUS
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
Generic NameEMBOLECTOMY CATHETER
Product CodeDXE
Date Received2020-03-11
Model Numbere1651-84
Catalog NumberE1651-84
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-11

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