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

Catalog Number	1801-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for investigation.The reported problem was confirmed.The balloon was observed to be ruptured.While the reported event was confirmed, the exact root cause of the balloon rupture could not be determined.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.The ifu states: complications associated with the use of embolectomy catheters include, but are not limited to: systemic infection, local hematomas, intimal disruptions, arterial dissection, perforation and rupture, hemorrhage, arterial thrombosis, distal emboli of blood clots or arteriosclerotic plaque, air embolus, aneurysms, arterial spasms, arteriovenous fistula formations, and balloon rupture or tip separation with fragmentation and distal embolization.
Event or Problem Description
The balloon ruptured during the preparation.The amount injected into the balloon was appropriate.The operation was successfully completed using another catheter.No injury was reported to the patient.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP
• Common Device Name: 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 17869681
• Report Number: 1220948-2023-00173
• Device Sequence Number: 12250525
• Product Code: DXE
• UDI-Device Identifier: 00840663100910
• UDI-Public: (01)00840663100910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1801-44
• Device Lot Number: NSE2698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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