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

Catalog Number	1601-48
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not yet received the device for evaluation.Hence, we could not conclusively determine the root cause of the defect.As part of our manufacturing process, a 100% balloon and winding inspection are performed on the manufactured product.However, it is possible that the tension or the glue applied underneath the balloon prior to the balloon tying process was inadequate resulting in the slippage of the ligature from its position.Although we are inconclusive about the root cause of the defect, it is also possible that the balloon separated as a result of excessive pull force that was applied to remove adherent material during the procedure.It is possible that the 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.To minimize the risk of balloon rupture/separation, maximum recommended inflation volume and pull force for the catheter should not be exceeded.We currently have a corrective and preventive action (capa) opened to investigate the possible root causes of this issue.We have contacted the distributor who reported this incident to us several times for additional information on this incident but we were unable to receive any more information.
Event or Problem Description
This is report 1 of 2 (please refer to 1220948-2018-00041 for another report).Catheter balloon detached completely from the catheter shaft during the embolectomy procedure.

• 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: 7631223
• Report Number: 1220948-2018-00040
• Device Sequence Number: 11230664
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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): 06/22/2018

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: 05/28/2023
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC4254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: Required Intervention