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

Catalog Number	1601-68
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.The proximal ligature was observed to have partially unwound.The balloon was observed to have partially inflated beyond the inflation holes.As a result, the user could not deflate the balloon.The distal ligature was properly binding onto the shaft of the catheter.No necking or kinking of the extrusion was observed.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.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% visual balloon and winding inspection are performed on the manufactured product.However, it is possible that the tension or the glue applied underneath the balloon during the balloon tying process was inadequate resulting in the slippage of the ligature from its position.It is also possible that some anatomical or procedural factors may have contributed to the ligature failure while removing the adherent material from the patient's narrowed blood vessel.As stated in our ifu, 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.There was no injury to the patient as the result of this incident.Another lemaitre over-the-wire embolectomy catheter was used to complete the procedure.
Event or Problem Description
During thrombectomy of arteriovenous fistula of upper limb prosthesis, surgeon observed that he could not deflate the balloon of the single lumen catheter.The malfunction was detected after removing a part of the thrombus while the catheter was outside the patient's blood vessel.There was no injury to the patient as the result of this incident.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8775437
• Report Number: 1220948-2019-00086
• Device Sequence Number: 1845873
• Product Code: DXE
• UDI-Device Identifier: 00840663100521
• UDI-Public: 00840663100521
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K992368
• 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): 07/09/2019

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: 07/28/2024
• Device Catalogue Number: 1601-68
• Device Lot Number: SLC4701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1