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

Model Number	A4E01
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported being confused about the size of the catheter for the syntel silicone over-the-wire embolectomy catheter product line.The reported issue was confirmed.The product uses only one catheter french size, but different size balloons.Although the outer diameter symbol should indicate 5f for all models, our product labels list them as 3f-7f (the corresponding size which each replaces based on balloon size.) it was thought that having different french sizes listed would be helpful for operating room staff for choosing the catheter needed for the operation.It was determined that all devices with pyt lot prefixes for catalog #s a4e01, a4e02, a4e03, a4e04, a4e08 and a4e09 are affected by this issue.This is the only complaint related to the reported issue.No adverse reactions have been reported related to this problem.This is identified as a labeling issue that does not put the patient at risk.The ifu cautions the user not to exceed the maximum inflated volume capacity.A corrective and preventive action (capa) has been initiated to address the issue.
Event or Problem Description
An email was recieved from a customer asking why they received a 3f syntel otw embolectomy catheter when they had ordered a 5f.In digging into this we uncovered that while the ifu lists all of the catheters as 5f diameter, our product labels list them as 3f-7f (the corresponding size which each replaces based on balloon size).This is identified as a labeling issue that is not likely to cause adverse health consequences.

• 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 15414098
• Report Number: 1220948-2022-00096
• Device Sequence Number: 12172276
• Product Code: DXE
• UDI-Device Identifier: 00840663109869
• UDI-Public: 00840663109869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: A4E01
• Device Catalogue Number: A4E01
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/13/2022
• 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