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

Model Number	45026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776); Nausea (1970); Ventricular Tachycardia (2132)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8636753
• Report Number: 2134265-2019-05655
• Device Sequence Number: 1858347
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K133629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR