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 Bradycardia (1751); Chest Pain (1776); Nausea (1970); Ventricular Tachycardia (2132)

Event Date 04/26/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced bradycardia and ventricular tachycardia during the procedure.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's heart rate was in the 80's then it dropped to the 30's.There was a significant amount of pain in the chest/lungs and the procedure had to be stopped.Almost immediately after the use of the angiojet, the patient went into ventricular tachycardia.After the procedure, the patient felt the need to vomit.

Event Description

It was reported that the patient experienced bradycardia and ventricular tachycardia during the procedure.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's heart rate was in the 80's then it dropped to the 30's.There was a significant amount of pain in the chest/lungs and the procedure had to be stopped.Almost immediately after the use of the angiojet, the patient went into ventricular tachycardia.After the procedure, the patient felt the need to vomit.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: 8636753
• MDR Text Key: 145951279
• Report Number: 2134265-2019-05655
• 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: 01/27/2021
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0023537502
• 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): Other
• Patient Age: 71 YR