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

Catalog Number	2103-56
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned for evaluation.The reported issue was confirmed.The balloon of the device was observed to be ruptured.While the reported event was confirmed, the exact root cause of the balloon rupture could not be determined.However, it was stated the cause of the rupture appears to be incidental contact with the metal part of the stent.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
The pruitt occlusion catheter (poc) and xenosure were used in one case of endarterectomy + evt.After endarterectomy of the right femoral artery and placement of a metal stent, the shaft of the poc was inserted into the vessel to place a patch at the endarterectomy site.However, the balloon of the poc ruptured, so the blood flow could not be blocked.Since the stent was placed on the proximal side of the endarterectomy site, it was not possible to occlude the blood vessel using vascular clamp.So, pta balloon was used instead to occlude the blood flow.The xenosure patch was sutured to the endarterectomy site and the surgery was completed.The patient is doing well and there were no health complications.The cause of the balloon rupture appears to be contact with the metal part of the stent.

• Brand Name: PRUITT IRRIGATION OCCLUSION CATHETER
• Common Device Name: OCCLUSION 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 18865689
• Report Number: 1220948-2024-00058
• Device Sequence Number: 12796015
• Product Code: DYG
• UDI-Device Identifier: 00840663101573
• UDI-Public: (01)00840663101573
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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: 02/28/2024
• Device Catalogue Number: 2103-56
• Device Lot Number: POC1732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2017
• 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