MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

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  

Manufacturer Narrative

It was reported that angiojet ultra 5000a used in the procedure either had serial # (b)(4).Model number: either 45043 or 45038; catalog number: either 45043 or 45038; serial number: either (b)(4); expiration date: either 12/09/2031 or 08/07/2025; unique identifier (udi) #: either (b)(4); device manufacture date: either 09/13/2018 or 07/24/2015.

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.

Manufacturer Narrative

It was reported that angiojet ultra 5000a used in the procedure either had serial # (b)(4).Model number: either 45043 or 45038.Catalog number: either 45043 or 45038.Serial number: either (b)(4).Expiration date: either 12/09/2031 or 08/07/2025.Unique identifier (udi) #: (b)(4).Device manufacture date: either 09/13/2018 or 07/24/2015.

Manufacturer Narrative

It was reported that angiojet ultra 5000a used in the procedure either had serial # (b)(4).D4: model number: either 45043 or 45038.D4: catalog number: either 45043 or 45038.D4: serial number: either (b)(6).D4: expiration date: either 12/09/2031 or 08/07/2025.D4: unique identifier (udi) #: either (b)(6).H4: device manufacture date: either 09/13/2018 or 07/24/2015.Device evaluated by mfr: there are two possible angiojet consoles that could have been used in this procedure; serial number u5050 or u2843.Neither console was returned for evaluation.The field service engineer (fse) tested both angiojet consoles at the site of the customer.Field service engineer (fse) was unable to find anything wrong with the angiojet consoles.The systems passed all functional and electrical safety testing without any issue.

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 ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8636727
• MDR Text Key: 145950512
• Report Number: 2134265-2019-05656
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

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
• 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; 07/22/2019
• Supplement Dates FDA Received: 06/27/2019; 07/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR