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

Catalog Number	1601-38
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.The balloon and a part of the distal lumen was observed to have separated from the catheter shaft.We observed excessive necking at the end of the catheter shaft.The distal end of the catheter shaft had stretched more than twice of its original length.We were unable to flush the inflation lumen since it was completely occluded due to necking.We observed the proximal and distal ligature of the balloon was properly holding onto its catheter shaft.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.As part of our manufacturing process, a 100% balloon and winding inspection are performed on each of the manufactured product.Device operated properly during pre-use check and during the first two passes.The malfunction occured during the third pass.Based on our device evaluation and incident report, it is likely that the patient's anatomical factors (stenosis in the lesion area) along with the procedural factors (use of excessive force to remove the thrombus) could have contributed to this device failure.As is common with other catheterization procedures, complications including tip separation may occur during use of embolectomy catheters.Our ifu properly identifies the risks associated with the use of the lemaitre over-the-wire catheters to its users.To minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.Surgeon was able to retrieve the catheter tip from the patient's vessel.The stenotic region was surgically repaired using artificial blood vessel.
Event or Problem Description
During thrombectomy of a hemodialysis patient with stenosis, lemaitre over-the-wire embolectomy catheter was used to remove the thrombus.Thrombectomy was performed multiple times above the stenosis region with an attempt to remove the thrombus.During third pass, the inflated balloon could not pass beyond the stenotic region.Although surgeon attempted to deflate the balloon multiple times, he was unable to do so.Surgeon reluctantly pulled the catheter to remove it from the patient's vessel.As a result of this, the tip of the catheter separated from the catheter shaft.Surgeon was able to retrieve the catheter tip from the patient's vessel.The stenotic region was surgically repaired using artificial blood vessel.

• 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: 8926633
• Report Number: 1220948-2019-00115
• Device Sequence Number: 253605
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: 00840663100668
• Combination Product (Y/N): N
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Catalogue Number: 1601-38
• Device Lot Number: OTW3971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention