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

Model Number	1651-48
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received and evaluated the complaint device.When we injected liquid into the inflation lumen, we could not inflate the balloon as we experienced extreme resistance when pushing the plunger of the syringe.We observed both ligatures were properly intact in its intended location and there was no any signs of balloon deformation.We observed a kink at 40-50 cm mark.However, when we cut the lumen below the kink, we still experienced resistance inflating the balloon.When we cut the lumen 10 cm above the tip of the y-connector, we were able to easily flush the inflation lumen.When we cut the catheter lumen at 60-70 cm at multiple locations, we observed tacky, crystallized material in the inflation lumen.Based on our evaluation, it is possible that an extremely viscous dye was used for inflating the balloon at the hospital that may have occluded the inflation lumen.We could not confirm the lot number of this complaint device.However, user informed the lot number of the complaint device is either (b)(4).Our review of the lot history records for these two lots did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from these lots.There was no harm to the patient as the result of this incident.Surgeon used another over-the-wire embolectomy catheter to complete the procedure.
Event or Problem Description
During pre-use check, when surgeon inflated the balloon of the over the wire embolectomy catheter, he observed the tip of the balloon inflated in a distorted shape.He also experienced excessive resistance when inflating the balloon.The malfunction was found during pre-use check.Surgeon used another over-the-wire embolectomy catheter to complete the procedure.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11578315
• Report Number: 1220948-2021-00033
• Device Sequence Number: 19738516
• Product Code: DXE
• UDI-Device Identifier: 00840663100682
• UDI-Public: 00840663100682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2021

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: 1651-48
• Device Catalogue Number: 1651-48
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1