MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LEMAITRE EMBOLECTOMY CATHETER

Model Number	1601-48
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since the device is currently at the user facility.Hence, we could not conclusively determine the root cause of this incident.In the video that was provided to us, we observed the surgeon was unable to push the syringe's plunger when she attempted to inflate the balloon.We observed the balloon was fully deflated at this time.We did not observe any ligature deformation.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.The surgeon detected the malfunction during the pre-use check.So, he did not use this device for the embolectomy procedure.
Event or Problem Description
The balloon of the lemaitre embolectomy catheter failed to deflate during the pre-use check.The surgeon did not use the device for the embolectomy procedure.

• Brand Name: LEMAITRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 13518284
• Report Number: 1220948-2022-00008
• Device Sequence Number: 17261650
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2026
• Device Model Number: 1601-48
• Device Catalogue Number: 1601-26
• Device Lot Number: SLC5383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown