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

Catalog Number 1651-48

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation.We have confirmed the reported incident.The proximal ligature has slipped above the skive hole.As a result, the balloon could not deflate.We did not observe any necking of the catheter lumen and the catheter length was measured to be within specification.We observed multiple kinks in the catheter lumen at 20-30 cm and 60-70 cm mark.When the catheter lumen was cut above the 70 cm mark and we attempted to flush the inflation lumen, we were able to flush the lumen but we experienced resistance when pushing the plunger of the syringe.We then cut the lumen below the 20 cm mark and attempted to flush the inflation lumen.We were able to flush the lumen easily.Based on our evaluation, it is possible that the multiple kinks that we observed in this catheter might have contributed to the balloon deflation issue during the procedure and led to ligature slippage as the surgeon was removing the catheter from the patient's vessel.It is also possible that the ligature was not sufficiently tied to the catheter lumen resulting in the ligature slippage.We have requested the user to provide us with additional information relating to this incident.We have not yet received a response back form the customer.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.As part of our manufacturing process, a 100% balloon and winding inspection are performed on each of the manufactured product.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.There was no harm to the patient as the result of this incident.Surgeon used another lemaitre over-the-wire embolectomy catheter to complete the procedure.

Event Description

During thrombectomy, surgeon was unable to deflate the balloon of the lemaitre over-the-wire embolectomy catheter.The operation was successfully completed using another lemaitre over-the-wire embolectomy catheter.There was no harm to the patient as the result of this malfunction.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7212212266
• MDR Report Key: 11028003
• MDR Text Key: 231798504
• Report Number: 1220948-2020-00121
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW4306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• 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