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

Catalog Number	1601-44
Medical Device Problem Codes	Inflation Problem (1310); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we were able to confirm the reported incident.We observed that the proximal ligature was unwound and most parts of the balloon was missing.Device was checked before the procedure by the physician and was found to be operational.It is possible that the balloon was pulled with excessive force to remove the clot during the procedure resulting in this issue.Tortuous anatomy of the patient, calcified plaque if present in the patient's vessel and excessive tension on the device during the procedure could also lead to this failure.As stated in ifu, to minimize the risk of balloon rupture/separation, maximum recommended inflation volume and pull force for the catheter should not be exceeded.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.We perform 100% inspection on each device to ensure that the ligature properly binds to the shaft and an adequate amount of glue is present in the ligature.However, it is also possible that the tension on the ligature or the glue applied underneath the balloon prior to the balloon tying process was inadequate in this device resulting in the unwinding and slippage of the proximal ligature from its intended position.We have not received any other complaints of a similar nature for devices from this lot.We have opened a corrective and preventive action (capa) to address this issue.There was no injury to patient.
Event or Problem Description
During embolectomy procedure, after locating the balloon of the single lumen catheter (catalog#: 1601-44; lot#: slc4417) proximal to the blood clot, physician pulled the balloon to remove the adherent material.However, he did not feel any resistance while doing so.When he pulled the catheter from the vessel, he observed that the proximal ligature of the balloon had loosened and the balloon had deflated.

• 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: 7652951
• Report Number: 1220948-2018-00045
• Device Sequence Number: 159308
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

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: Physician
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC4417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/29/2018
• 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: Other