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

Model Number	A4F04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We have confirmed the reported incident.We observed the ligature slipped off the tip of the catheter causing the balloon to become unfastened from the distal end of the catheter.Based on the evaluation of the returned unit, it is likely that the ligature was in installed correctly due to an error during tying or gluing of the ligature.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.Further, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
The product was prepared for embolectomy in the autologous blood vessels of dialysis patient.The catheter was inserted into the blood vessel, then the balloon was inflated.When the physician started pulling the catheter for removing the clots, the balloon ruptured without any resistance.When he took the catheter out of the vessel and checked it, there was something like a ligature and a piece of the balloon on the catheter tip.He gave up using this product and replaced it with another catheter of the same size.The procedure was successfully completed using that catheter.The patient is fine.There was no health impact to the patient.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - SPRING TIP
• Common Device Name: CATHETER, EMBOLECTOMY
• 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15262631
• Report Number: 1220948-2022-00080
• Device Sequence Number: 5633548
• Product Code: DXE
• UDI-Device Identifier: 00840663109654
• UDI-Public: 00840663109654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K901627
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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 Expiration Date: 10/28/2025
• Device Model Number: A4F04
• Device Catalogue Number: A4F04
• Device Lot Number: SSE1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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