MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC TUFTEX EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Catalog Number A4F05

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

The balloon of the syntel spring tip embolectomy catheter ruptured during a thrombectomy procedure.

Manufacturer Narrative

We have not received the complaint device for investigation.Hence, we could not conclusively determine the root cause of the issue.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 of a similar nature for devices from this lot.The user facility has also reported the incident to fda ( report# (b)(4)).We have contacted the user facility for additional information.We have not received a response yet.

• Brand Name: TUFTEX EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• MDR Report Key: 12564201
• MDR Text Key: 281758822
• Report Number: 1220948-2021-00089
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• PMA/PMN Number: K992368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4F05
• Device Lot Number: SSE1074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1