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

Model Number	A4F04
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using a syntel silicone embolectomy catheter - spring tip for removal of a clot the balloon ruptured.There was no injury to the patient.The operation was successfully completed with a replacement device.
Additional Manufacturer Narrative
The product was received for evaluation and the reported issue was confirmed.The balloon of the catheter was observed to be ruptured.Based on the damaged and the tear in the balloon beginning at the proximal side of the balloon and moving distally, the balloon appeared to be damaged due to the force of pulling the catheter during the procedure.It is possible the balloon came into contact with a sharp area or calcified plaque during removal.The lot number for the device was unable to be determined.Therefore, a device history record could not be reviewed for this device.Due to the nature of the procedure this device is used in, balloon rupture is an inherent risk when using this device.As stated in the ifu: complications associated with the use of embolectomy catheters include, but are not limited to: systemic infection, local hematomas, intimal disruptions, arterial dissection, perforation and rupture, hemorrhage, arterial thrombosis, distal emboli of blood clots or arteriosclerotic plaque, air embolus, aneurysms, arterial spasms, arteriovenous fistula formations, and balloon rupture or tip separation with fragmentation and distal embolization.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - SPRING 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16682219
• Report Number: 1220948-2023-00049
• Device Sequence Number: 7226503
• Product Code: DXE
• UDI-Device Identifier: 00840663109654
• UDI-Public: (01)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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: A4F04
• Device Catalogue Number: A4F04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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