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

Catalog Number	1801-48
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it took a considerable amount of time to deflate the balloon.Also, it seems that the balloon of this product inflated asymmetrically.Therefore, the physician discontinued using the device.A replacement device with the same lot number was used to complete the operation.No injury was reported to the patient.
Additional Manufacturer Narrative
The devices was recieved for investigation.The reported problem was confirmed.The lower ligature was observed to have slipped from its intended position which caused the balloon to move past the skive hole and prevented the balloon from deflating.The ligature likely failed due to the pull force on the catheter during the procedure.It is possible that procedural factors including stenosis or calcified plaque caused additional pull force to be used during thrombus removal and contributed to the failure.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.Additionally, there have not been any previous complaints related to this lot number.

• 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 ; 7814251683
• MDR Report Key: 18575632
• Report Number: 1220948-2024-00021
• Device Sequence Number: 9080280
• Product Code: DXE
• UDI-Device Identifier: 00840663100927
• UDI-Public: (01)00840663100927
• 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): 01/24/2024

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: 1801-48
• Device Lot Number: NSE2664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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