MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER

Catalog Number	A4E04
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.According to the user the product was tested/flushed prior to use and no issues were noted.Therefore, it is likely that the damage occurred while handling the device during the procedure.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.
Event or Problem Description
It was reported that the syntel otw has a pin hole at hub of working end and blood was squirtting out.A new catheter was used.Patient was bleeding and on the table longer than expected.No further complications or injury was reported.Patient was doing fine after the procedure.

• Brand Name: SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 19565828
• Report Number: 1220948-2024-00117
• Device Sequence Number: 17883293
• Product Code: DXE
• UDI-Device Identifier: 00840663109890
• UDI-Public: (01)00840663109890
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K202049
• 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): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A4E04
• Device Lot Number: PYT1146
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown