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

Model Number 45026

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

Patient Problems Cardiopulmonary Arrest (1765); Chest Pain (1776); Death (1802); Loss of consciousness (2418)

Event Date 04/24/2019

Event Type  Death  

Event Description

It was reported a patient death occurred.The patient experienced chest pain and loss of consciousness.An angiojet avx catheter and an angiojet console were selected for use in a declot procedure in the left arm.During the procedure, the patient experienced significant swings in and out of consciousness, was out of breath and felt tired; however the patient's heart rate remained stable.When being discharged, the patient complained of having to burp, but could not.The patient experienced pain in the chest and was taken to the emergency room where the patient coded and died.

Event Description

It was reported a patient death occurred.The patient experienced chest pain and loss of consciousness.An angiojet avx catheter and an angiojet console were selected for use in a declot procedure in the left arm.During the procedure, the patient experienced significant swings in and out of consciousness, was out of breath and felt tired; however the patient's heart rate remained stable.When being discharged, the patient complained of having to burp, but could not.The patient experienced pain in the chest and was taken to the emergency room where the patient coded and died.It was further reported that the case was for a graft or fistula in a hemodialysis patient.

• Brand Name: ANGIOJET AVX
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8636757
• MDR Text Key: 145951108
• Report Number: 2134265-2019-05659
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (y/n): N
• PMA/PMN Number: K133629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 01/26/2021
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0023536296
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR