MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Catalog Number A4F05

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2021

Event Type  malfunction  

Event Description

During the thrombectomy procedure, a size 4 fogarty catheter (ref #: a4f05 and lot #: (b)(4) balloon had burst open while being used on the patient.It was discovered after using and discarding the catheter.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• MDR Report Key: 12567800
• MDR Text Key: 274494747
• Report Number: 12567800
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2021

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 Catalogue Number: A4F05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA
• Patient Weight: 73