MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT OCCLUSION CATHETER

Model Number	2103-36
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The balloons of the four pruitt occlusion catheters ruptured during a tea procedure in a patient.There was no harm to the patient because of this incident.This is report 4 of 4.
Additional Manufacturer Narrative
We have not received the complaint devices for evaluation.Hence, we could not conclusively determine the root cause of the incident.During the follow-up investigation, we were informed that the catheters were used for a vessel occlusion and the balloons ruptured immediately.Based on the reported incident, it is likely that the balloons came in contact with the calcified region of the vessel as they were used during a thrombo-endarterectomy procedure.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 from other customers of a similar nature for devices from this lot.Please note that we have also reported manufacturer incident report# 1220948-2022-00059, 1220948-2022-00060 and 1220948-2022-00061 relating to other three cases of balloon rupture with pruitt occlusion catheters that occurred during this same case.

• Brand Name: PRUITT OCCLUSION CATHETER
• Common Device Name: OCCLUSION CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave 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: 15013585
• Report Number: 1220948-2022-00063
• Device Sequence Number: 16736223
• Product Code: DYG
• UDI-Device Identifier: 00840663101559
• UDI-Public: 00840663101559
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K811276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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 Model Number: 2103-36
• Device Catalogue Number: 2103-36
• Device Lot Number: QPO1043
• 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: 06/14/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown