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

Catalog Number	1601-48
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/13/2018
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.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 had led 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 during the balloon tying process was inadequate in this device resulting in the unwinding of the ligature.It could not be determined if some anatomical or procedural factors may have contributed to the balloon rupture.We have requested for additional information from the hospital related to this incident.However, we have not received any response back from the hospital.We currently have a corrective and preventive action (capa) to address this issue.
Event or Problem Description
During a thrombectomy procedure, while removing the thrombus, the catheter came out of the artery but the balloon attached to the catheter was missing.

• 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: 8011480
• Report Number: 1220948-2018-00090
• Device Sequence Number: 1382739
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/26/2018

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: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC4572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/28/2018
• 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