MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ANGIOJET® ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 105650-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

The assembly drawer was received in good condition with no physical damages observed.The angiojet ultra system console and catheter were not returned for evaluation.The drawer was installed into pm angiojet, tested and passed.No check saline supply during prime and power pulse mode seen at the time of testing.The drawer from pm console was removed and installed into drawer test fixture and tested.The angiojet ultra drawer passed all the steps of the functional test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as: 2134265-2018-01055.It was reported an error message occurred during use.The physician was performing a st-elevation myocardial infarction (stemi) case in the saphenous vein graft (svg) to the right coronary artery (rca) using an angiojet® ultra xmi® thrombectomy set, a spiroflex® angiojet® thrombectomy set and an angiojet® ultra system console.During priming outside the patient, the spiroflex displayed a "check saline tubing not primed" error.The ultra xmi was used for the first run in the svg; however a "check saline tubing not primed" error displayed.The device was removed and manual aspiration was used with a non-bsc catheter.No patient complications were reported.The vein graft was opened up; however all blood flow distal in the native rca was unable to be restored.The patient was converted to a do not resuscitate (dnr) and changed to hospice for palliative care.

• Brand Name: ANGIOJET® ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7286708
• MDR Text Key: 100780487
• Report Number: 2134265-2018-01539
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105650-001
• Device Catalogue Number: 105650-001
• Device Lot Number: U6022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR