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

Catalog Number	1801-58
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and not returned for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.It was noted the device was not pre-checked prior to use as instructed in the ifu.The lot history record for the devices was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.During manufacturing the balloons are 100% inspected to ensure that they are able to properly inflate/deflate.Additionally, the ligatures are 100% visually inspected to ensure that there are no gaps and that the windings are uniform and create a smooth transition from the balloon to the catheter shaft.They are also inspected to ensure there are no specs of fibers on the ligatures that could result in the reported failures.According to the device history record, during manufacturing all samples passed inspection and there were products rejected due to abnormalities related to the reported issue.This is report 2 of 2 related to the second catheter used in the event.Reports 1220948-2024-00201 was submitted for the first device involved in this event.
Event or Problem Description
It was reported that ligature loosened and unraveled from the catheter in a spiral manner.The pieces are still attached to the catheter and did not have to be removed from the vessel.This has occurred on 2 catheters from lot nse2924.The devices were not pre-checked prior to use.No injury was reported to the patient.Note: this is report 2 of 2 related to the second catheter used in the event.Reports 1220948-2024-00201 was submitted for the first device involved in this event.

• 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 ; 9784251683
• MDR Report Key: 20358906
• Report Number: 1220948-2024-00202
• Device Sequence Number: 7208458
• Product Code: DXE
• UDI-Device Identifier: 00840663100941
• UDI-Public: (01)00840663100941(11)231010(17)280928(10)NSE2924(91)1801-58
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/03/2024

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: NSE2924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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