MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE THROMBECTOMY CATHETER; EMBOLECTOMY CATHETER

Model Number	A4545
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the syntel silicone thrombectomy catheter broke off during the thrombectomy procedure.No injury occurred.
Additional Manufacturer Narrative
The product was received for evaluation.The balloon of the catheter was observed to slip and retract slightly from the distal portion of the catheter as a result of the ligature failing to hold the balloon in place.Since the balloon no longer covered the distal end of the catheter tip, it allowed fluid to leak out of the tip instead of inflating the balloon.This prevented the device from functioning as intended.This issue is due to an operator error while tying or gluing the distal ligature of the device.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.Additionally, we have not received any reports of similar issues occurring for this lot.

• Brand Name: SYNTEL SILICONE THROMBECTOMY CATHETER
• 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16477910
• Report Number: 1220948-2023-00023
• Device Sequence Number: 3198599
• Product Code: DXE
• UDI-Device Identifier: 00840663109807
• UDI-Public: (01)00840663109807
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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 Model Number: A4545
• Device Catalogue Number: A4545
• Device Lot Number: SST1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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