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

Catalog Number	1801-58
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that four syntel silicone embolectomy catheter - regular tip balloon ruptured during use.No injury was reported to the patients.More information in regard to the reported incidents were requested.Note: this is report 1 of 4 related to the first catheter used in the event.Reports 1220948-2024-00188, 1220948-2024-00189, and 1220948-2024-00190 were submitted for the second, third, and forth devices involved in this event.
Additional Manufacturer Narrative
We have not received the device for evaluation.Therefore, we could not conclusively determine the root cause of the incident.Balloon rupture is a known complication with this type of product and is not an indication of a systemic issue with the product.As stated in the ifu: in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, plaque, arterial dissection, and hemorrhage.Exposure to calcified plaques may increase the risk of balloon rupture.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any similar complaints related to this lot number.Note: this is report 1 of 4 related to the first catheter used in the event.Reports 1220948-2024-00188, 1220948-2024-00189, and 1220948-2024-00190 were submitted for the second, third, and fourth devices involved in this event.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP
• Common Device Name: EMBOLECTOMY CATHETER - REGULAR TIP
• 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
• MDR Report Key: 20297838
• Report Number: 1220948-2024-00187
• Device Sequence Number: 7588727
• Product Code: DXE
• UDI-Device Identifier: 00840663100941
• UDI-Public: (01)00840663100941(11)220407(17)270328(10)NSE2431(91)1801-58
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K992368
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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 Catalogue Number: 1801-58
• Device Lot Number: NSE2431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2022
• 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