MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZELANTEDVT CLOTHUNTER HELICAL ROTATION DEVICE

Model Number	2128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776)
Date of Event	10/20/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that cardiac arrest and death occurred.The patient was undergoing treatment for deep vein thrombosis.Heparin was infused prior to the case.A zelantedvt clothunter helical rotation device and zelantedvt catheter were selected for use.After power pulse was performed, the clothunter was inserted and run proximal to distal through the treatment area.The clothunter was then advanced for a second run through the treatment area when the patient experienced chest pain and became unresponsive.The patient experienced a cardiac arrest and ultimately passed away.

• Brand Name: ZELANTEDVT CLOTHUNTER HELICAL ROTATION DEVICE
• Common Device Name: CLOTHUNTER HELICAL ROTATION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12791339
• Report Number: 2134265-2021-13901
• Device Sequence Number: 5645101
• Product Code: QEW
• UDI-Device Identifier: 08714729968740
• UDI-Public: 08714729968740
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K202218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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 Expiration Date: 03/11/2023
• Device Model Number: 2128
• Device Catalogue Number: 2128
• Device Lot Number: 0026956326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female