MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number	1601-26
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Embolectomy catheter broke during use surgically.Further arterial exploration required to ensure no foreign body/part of broken catheter in situ.Embolectomy catheter was matched against another (new) catheter to confirm all broken parts were accounted for.
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we confirmed the reported incident.We received two catheter pieces.The catheter shaft of the first piece was measured to be 67 cm and it contained the catheter hub.The other piece was measured to be 10 cm.We did not observe a balloon attached to either piece.Based on our device evaluation, it is likely that some procedural factors ( use of excessive force to remove the clot) may have caused or contributed to this malfunction.As is common with other catheterization procedures, complications including tip separation may occur during the use of embolectomy catheters.Our ifu properly identifies the risks associated with the use of the single lumen catheter 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.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 products.

• Brand Name: LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• MDR Report Key: 12719567
• Report Number: 1220948-2021-00104
• Device Sequence Number: 11758301
• Product Code: DXE
• UDI-Device Identifier: 00840663100446
• UDI-Public: 00840663100446
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K992368
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2025
• Device Model Number: 1601-26
• Device Catalogue Number: 1601-26
• Device Lot Number: SLC5195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 10/29/2021
• 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