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

Model Number 105650-001Z

Device Problems Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problem Embolism (1829)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

Patient age at time of event: 18 years or older.Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A service history review was performed and nothing was found to indicate a possible service-related cause for the complaint.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

Same case a mdr id#2134265-2017-12502.It was reported that the device was aspirating without infusion.An angiojet solent omni thrombectomy catheter and angiojet® ultra system console were used for an arterial clot treatment procedure in the right common femoral artery and distal common iliac artery.The device was used in power pulse mode to deliver 80 cc of lytic into the thrombus.The catheter was removed from the patient and waited 20 minutes.The same solent omni catheter advanced back into the patient and regular thrombectomy mode activated for approximately 50 seconds when an error occurred.The console was reset and error occurred two more times.The catheter was removed and reset in the console, successfully re-primed, advanced to the thrombus, activated and another error message occurred.The device was removed from the console and staff noticed saline in the console drawer and wiped out.The catheter was replaced with another solent omni catheter and a new 500 cc heparinized saline bag directly spiked into the catheter.The catheter was primed and advanced to the treatment site.The device was run in thrombectomy mode for 250 seconds when an error occurred (bubble check line).The device was removed, re-primed and re-inserted into the patient.The error continued to occur until a catheter exchange message occurred.At this time the staff noticed saline in the console drawer.It was also noticed that the level in the saline bag did not appear to have changed (500 ml bag appeared to still be 500 ml bag) but there was approximately 100 cc of blood in the waste bag.The clot they were treating migrated distally.The physician as able to complete the procedure with a solent dista thrombectomy catheter.There were no patient complications and the patient was stable but his symptoms were unchanged (pain in right leg).The patient was put on a lytic drip with an additional treatment procedure the next day.

• 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: 7095830
• MDR Text Key: 94122963
• Report Number: 2134265-2017-12553
• 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: 11/08/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 105650-001Z
• Device Catalogue Number: 105650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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 Outcome(s): Other