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	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received and evaluated the complaint device.We observed that the proximal ligature has slipped 1 cm towards the tip from its intended location.We also observed necking on a section of the catheter shaft just below the proximal ligature.Surgeon must have used an excessive force to remove the thrombus during the thrombectomy procedure which caused ligature slippage and then necking of the catheter shaft.As a result of this, the balloon was unable to deflate during the procedure.When we cut the catheter 1 inch below from the tip of the catheter, we also observed glue like particles in the inflation lumen.Even after cutting the catheter shaft below the location of the necking, we were still unable to flush the inflation lumen.We did not observe any kink or any necking in the catheter lumen.The source of the foreign material is unknown at this time.However, it is likely introduced by the user during the procedure since he was able to inflate the balloon at the beginning of the procedure.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.We have initiated a corrective and preventive action (capa) to investigate the source of such foreign material inside the inflation lumen of the catheter.Please note that our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality suggesting that these particles were likely introduced inside the catheter lumen during post-production or during the procedure at the hospital.There was no harm to the patient as a result of this incident.The surgeon used another 4f over-the-wire embolectomy catheter to complete the procedure.
Event or Problem Description
During thrombectomy in a dialysis patient, the surgeon inserted the catheter shaft into the blood vessel.He inflated the balloon to remove the thrombus.When he tried to deflate the balloon just before the stenosis, he was unable to do so.There was no harm to the patient as a result of this incident.The surgeon used another 4f 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: 12010279
• Report Number: 1220948-2021-00061
• Device Sequence Number: 4328937
• 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): 06/16/2021

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 Expiration Date: 07/28/2025
• Device Model Number: 1651-48
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW4253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1