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

Catalog Number	1601-38
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation since the device has been discarded by the hospital.Hence, we could not conclusively determine the root cause of the defect.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 similar nature for devices from this lot.The procedure was completed successfully using another catheter from stock.The patient was previously intubated in icu with multi-organ failure when her aorto-femoral graft thrombosed and her leg became critically ischaemic.A femoral thrombectomy was performed and calf fasciotomies.The patient had known pvd with multiple revascularizations in the past and a heavy smoker.The balloon fragment was seen on ct a week or so later in the deep distal thigh and has caused no further clinical issues.Doctor determined it was safer to leave it in-situ.Patient recovered remarkably quickly post op.No adverse events.We currently have a corrective and preventive action (capa) opened to investigate the root cause 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.We do perform a periodic pull test on these devices to ensure that the ligatures are strong enough and are properly binding to the shaft.All of the units that were tested around the timeframe when this unit was built had passed the pull test.At this time, we are inconclusive about the root cause of this defect.
Event or Problem Description
During a femoral artery embolectomy procedure, the balloon of the embolectomy catheter ruptured and sheared away from the catheter.The tip was not retrieved from the patients vessel.

• 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: 7053876
• Report Number: 1220948-2017-00065
• Device Sequence Number: 1874504
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/22/2017

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: 10/28/2022
• Device Catalogue Number: 1601-38
• Device Lot Number: SLC4077
• 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: 10/24/2017
• Initial Report FDA Received Date: 11/22/2017
• 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
• Patient Age: 60 YR