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

Model Number 1601-48

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

We have received the catheter as well as the dislodged catheter tip for evaluation.The catheter broke just below the proximal ligature.The distal end of the catheter shaft where it separated was observed to have stretched extensively.The last 8 cm stretched to 18 cm ( 44% elongation).As a result, the inflation hole was completely occluded.The proximal ligature was partially undone but did not show any sign of slippage.The distal ligature remained intact and properly secured to the shaft of the catheter.During our follow-up conversation with the contact person at the hospital, we learned that the malfunction occurred during the second pass.Surgeon was unable to deflate the balloon when he attempted to remove the catheter from the patient's vessel.The contact person also stated that the pictures from the angiogram taken prior to the surgery did not show extensive calcification or stenosis in the patient's artery.She could not confirm if the catheter was used to remove a fresh clot or an adherent mature clot.Based on our device evaluation, it is likely that some procedural factors ( use of excessive force to remove the clot) may have contributed to this malfunction.The necking of the catheter shaft that we observed in this catheter likely resulted due to excessive force that was exerted when removing the clot which blocked the inflation lumen and prevented the balloon from deflating.As surgeon exerted additional force to remove this undeflated balloon from the vessel, it likely resulted in the tip separation.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 to ensure each catheter operates properly.We have performed a pull test on a sample of units from this lot number during our in-process inspection.All of those units passed the test requirements when the balloons were pull tested to their validated force.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of tip separation.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.As of the latest information received on 30/01/2020, patient was still at hospital, but doing well with no signs of complication from the malfunction.

Event Description

During thrombectomy in superficial femoral artery, catheter tip dislodged from the catheter shaft during removal of residual thrombi from the patient's vessel.The malfunction occurred during second pass.Surgeon was able to remove the catheter tip from the patient's vessel.The malfunction extended operating time period but did not result in any patient injury.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, ma ; 2212266152
• MDR Report Key: 9770750
• MDR Text Key: 188405342
• Report Number: 1220948-2020-00024
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 1601-48
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC4825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Disability