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

Catalog Number 2103-56

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 337214800
• Report Number: 1220948-2024-00058
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00840663101573
• UDI-Public: (01)00840663101573
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K811276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1