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

Catalog Number	E1801-34
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for investigation.However, the provided photos show the failure is due to the ligature slipping.Although it was reported that the issue was noted during pre-use testing, the provided photos appear to indicate that the product was used in the procedure it appears the the proximal ligature 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.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that during pre-use test, the balloon inflated with the normal saline, but could not be deflated.The operation was successfully completed using a replacement device.No injury was reported to the patient.

• 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: 20287023
• Report Number: 1220948-2024-00184
• Device Sequence Number: 8012291
• Product Code: DXE
• UDI-Device Identifier: 00840663101016
• UDI-Public: (01)00840663101016(11)231120(17)281028(10)NSE2935(91)E1901-34
• 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): 09/23/2024

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: E1801-34
• Device Lot Number: NSE2935
• 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: 08/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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