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

Model Number	1651-48
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed the balloon remained partially undeflated when we received the device.We observed both ligatures and balloon were intact.However, the proximal ligature has slipped over the inflation hole.As a result, the balloon remained undeflated.We did not observe any stretching in the catheter lumen.The total length of the catheter was measured to be only 1mm above the specification.Based on our investigation, it is possible that the balloon was not tied sufficiently to the catheter shaft.It is also possible that some anatomical (calcification or stenosis in the lesion area) or procedural factors (use of excessive force to remove the thrombus) may have contributed to the balloon failure.Our review of the lot history records for this lot 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 this lot.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials there was no harm to the patient as the result of this incident.The remaining procedure was completed using another lemaitre over-the-wire embolectomy catheter.
Event or Problem Description
After preuse check, the catheter was inserted into the vessel.Then, the balloon was inflated by the saline.During the thrombectomy (the exact number of times catheter was used to remove the clots was unknown), the balloon attempted to deflate, but it could not do.The catheter was removed from the blood vessel with the status of inflated balloon.The procedure was successfully completed with the replacement.

• 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: 10878568
• Report Number: 1220948-2020-00110
• Device Sequence Number: 4329387
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: 08/28/2025
• Device Model Number: 1651-48
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW4298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1