MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY

Model Number 45027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 03/09/2021

Event Type  Death  

Event Description

It was reported that the patient died.The target lesion was located in the subclavian vein.An angiojet zelantedvt was advanced for a mechanical thrombectomy procedure.During 257 seconds of using the device, the patient had a cardiorespiratory arrest.The physician performed cardiopulmonary resuscitation (cpr), however, the patient passed away.

• Brand Name: ANGIOJET ZELANTEDVT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11591625
• MDR Text Key: 243015293
• Report Number: 2134265-2021-04044
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024714511
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR