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

Model Number	e1601-24
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Manolidis was performing a decompression of patient's facial nerve through left intratemporal fossa approach.While using our tuftex embo cath, the balloon broke off in patient.This required the patient to undergo further ct imaging of head and neck, with potential for intracranial hemorrhage.The procedure was a left intratemporal fossa approach to skull base tumor, facial nerve decompression.The patient required a ct of both head and neck due to the potential of intracranial hemorrhage.The balloon was retrieved during the procedure.
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since the device is being retained by the site.Hence, we could not conclusively determine the root cause of the reported incident.The surgeon was able to retrieve and remove the balloon during the procedure.According to the ifu that is provided for this product, the tuftex embolectomy catheter is indicated for the removal of arterial emboli and thrombi.The tuftex embolectomy catheter should not be used for endarterectomy, dilating vessels or venous thrombectomy.The device in this event was used for a facial nerve decompression, which is considered off label use.The product is not intended to be used in nerve decompression procedures.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.

• Brand Name: TUFTEX EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15245397
• Report Number: 1220948-2022-00077
• Device Sequence Number: 5905831
• Product Code: DXE
• UDI-Device Identifier: 00840663100545
• UDI-Public: 00840663100545
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: e1601-24
• Device Catalogue Number: E1601-24
• Device Lot Number: QSL1070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 78 KG