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

Model Number	A4F05
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was received for evaluation.During evaluation, signs of use of the device were observed including blood on the device.The balloon of the catheter was observed to be ruptured.The exact cause of the balloon rupture could not be determined.The ifu provides the following warning regarding the possibility of balloon rupture when using this product: 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.Balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel.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.
Event or Problem Description
It was initially reported that the product was removed from the package and during the pre-use check the catheter could not be used due to leakage from the balloon.However, inspection of the device performed on 19dec2022 determined that the returned product had been used and found the balloon to be ruptured.Due to the device inspection, this event was reassessed to be a reportable event.

• 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: 16196288
• Report Number: 1220948-2023-00004
• Device Sequence Number: 4337976
• Product Code: DXE
• UDI-Device Identifier: 00840663109661
• UDI-Public: (01)00840663109661
• 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): 01/18/2023

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 Expiration Date: 10/28/2025
• Device Model Number: A4F05
• Device Catalogue Number: A4F05
• Device Lot Number: SSE1045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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