MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Event Description

It was reported that there was too little infusion with too much aspiration.An angiojet ultra system console and angiojet zelantedvt catheter were selected for thrombectomy of the deep vein thrombosis of the right subclavian vein.The procedure began with a puncture of the radial vein.Power pulse was used and 50 ml of thrombolytics were delivered as planned in the thrombus.After a couple of passes and activation time of approximately 200 seconds in thrombectomy mode, the vein had only a small passage.It was observed that the fluid in the waste bag was darker than normal.There was about 300 ml of fluid in the waste bag with only 100 ml of saline used.The console was checked by service and no faults were found.The catheter function was checked post procedure and it was working as usual.The patient was then treated with catheter based thrombolysis for 24 hours.There were no patient complications during the procedure.

Manufacturer Narrative

Device eval by manufacturer: the console was not returned for analysis.The device was reviewed onsite.The reported issue was unable to be reproduced.All functionality checks passed successfully.The reported console failure complaint was not confirmed onsite.

Event Description

It was reported that there was too little infusion with too much aspiration.An angiojet ultra system console and angiojet zelantedvt catheter were selected for thrombectomy of the deep vein thrombosis of the right subclavian vein.The procedure began with a puncture of the radial vein.Power pulse was used and 50 ml of thrombolytics were delivered as planned in the thrombus.After a couple of passes and activation time of approximately 200 seconds in thrombectomy mode, the vein had only a small passage.It was observed that the fluid in the wastebag was darker than normal.There was about 300 ml of fluid in the wastebag with only 100 ml of saline used.The console was checked by service and no faults were found.The catheter function was checked post procedure and it was working as usual.The patient was then treated with catheter based thrombolysis for 24 hours.There were no patient complications during the procedure.

• Brand Name: ANGIOJET ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8055998
• MDR Text Key: 126940172
• Report Number: 2134265-2018-62713
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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: 45038
• Device Catalogue Number: 45038
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR