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

Model Number	e1801-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the reported issue was discarded at the hospital and therefore not available for evaluation.The root cause of the reported issue could not be determined.We have reviewed the device history record for the involved lots.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 the involved lots.Please note that this is report 2 of 4 related to this incident.Reports 1220948-2022-00124, 1220948-2022-00126 and 1220948-2022-00127 were also filed in relation to the incident.
Event or Problem Description
A customer reported various issues have occurred while using the syntel silicone embolectomy catheter - regular tip devices.It was reported that the user had the balloon of the catheter rupture during use and they had to retrieve the broken piece with a snare.Additionally, the site reported three additional incidences of failures with this product.Two additional devices also had balloons rupture during use and one device had the balloon fail to deflate during use.No injuries were reported for these events.Please note that this is report 2 of 4 related to this incident.Reports 1220948-2022-00124, 1220948-2022-00126 and 1220948-2022-00127 were also filed in relation to the incident.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR 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: 15894164
• Report Number: 1220948-2022-00125
• Device Sequence Number: 17840807
• Product Code: DXE
• UDI-Device Identifier: 00840663101030
• UDI-Public: (01)00840663101030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K992368
• 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): 12/01/2022

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 Model Number: e1801-44
• Device Catalogue Number: E1801-44
• Device Lot Number: NSE2440 AND NSE2513
• 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: 11/02/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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