MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TRIVEX SYSTEM RESECTOR HANDPIECE

Catalog Number 7210387

Device Problem Failure to Conduct (1114)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the device for evaluation.When the run or the window lock button was pressed, drive fork did not rotate.Upon disassembly, the endbell's o-rings were observed to be damaged from incorrect assembly likely by someone at the user facility.Rtv under button appeared to have been removed and replaced.Endbell wires were observed to have mostly removed from their pins.We observed water ingress inside the core tube and board wires appeared to have been re-soldered.Upon removal of the drive fork, we observed quad rings and ball bearing instead of slip bearing which is inconsistent with how we built this device.The device appeared to have been disassembled by someone at the customer location with an attempt to repair.However, we were unable to confirm if the parts were swapped before or after the malfunction had occurred.Hence, at this time, we could not conclusively determine the cause of the failure due to device tampering by the user facility.Based on the condition this device was received, the surgeon would not be able to use this device for the phlebectomy procedure.However, we are reporting this incident as we do not have adequate information on how this device was handled before or after the event at the user facility.The issue was detected during pre-use check.Device was not used in the patient.

Event Description

During pre-use check, the blades of the resector did not spin.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• 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: 8923139
• MDR Text Key: 178780911
• Report Number: 1220948-2019-00112
• Device Sequence Number: 1
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 7210387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1