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

Catalog Number	1601-48
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and confirmed the failure.The balloon was separated from the catheter.From our investigation, we have found that this type of defect occurs when the lumen is pulled with too much force during the procedure.It is likely the device was pulled too hard causing the balloon to separate from the catheter.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.Further, we have not received any other complaints of similar nature for devices from this lot.It is also 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.We currently have a corrective and preventive action (capa) opened to investigate possible root causes of this issue.The corrective action includes review of our manufacturing processes, materials and handling of the device.We have also made our manufacturing team aware of this issue.At this time, we are inconclusive about the exact root cause of this defect.
Event or Problem Description
The balloon came off during the procedure.They were able to retrieve the balloon.

• 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: 7064815
• Report Number: 1220948-2017-00066
• Device Sequence Number: 16506602
• Product Code: DXE
• UDI-Device Identifier: 00840663100491
• UDI-Public: 00840663100491
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/28/2017

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: SLC4258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/28/2017
• 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; Required Intervention