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

Event Date 04/24/2019

Event Type  Death  

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 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.

Manufacturer Narrative

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

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.

Manufacturer Narrative

It was reported that angiojet ultra 5000a used in the procedure either had serial # (b)(4) or (b)(4).Model number: either 45043 or 45038 catalog number: either 45043 or 45038 serial number: either (b)(4) or (b)(4).Expiration date: either 12/09/2031 or 08/07/2025 unique identifier (udi) #: either (b)(4) or (b)(4).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 (b)(4) or (b)(4).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 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 ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8636755
• MDR Text Key: 145951272
• Report Number: 2134265-2019-05660
• 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; 07/19/2019
• Supplement Dates FDA Received: 06/27/2019; 07/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR