MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE EMBOLECTOMY CATHETER - SPRING TIP

Model Number A4F07

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint devices for evaluation.Hence, we could not conclusively determine the root cause of the incident.Balloon rupture may result from exposure to adverse environmental conditions, excessive handling or deposits within the vessel during the 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.

Event Description

During aortoiliac right lower extremity angiogram the syntel single lumen spring tip embolectomy catheter balloon broke.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - SPRING TIP
• Type of Device: 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16308213
• MDR Text Key: 308968656
• Report Number: 1220948-2022-00084
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663109685
• UDI-Public: (01)00840663109685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2023

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 Model Number: A4F07
• Device Catalogue Number: A4F07
• Device Lot Number: SSE1062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• 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