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

Model Number 45043

Device Problem Improper Flow or Infusion (2954)

Patient Problem Hematuria (2558)

Event Date 02/16/2021

Event Type  Injury  

Event Description

It was reported that haemoglobin urea was noticed.An angiojet ultra system console was used for a thrombectomy procedure.During the procedure under power pulse mode, it was noted that minimal backflow of 30cm of blood was flowing back into the catheter and also noticed generation of haemaglobin urea.Thrombectomy was performed for less than 240 seconds.No patient complications were reported.

Event Description

It was reported that haemoglobin urea was noticed.An angiojet ultra system console was used for a thrombectomy procedure.During the procedure under power pulse mode, it was noted that minimal backflow of 30cm of blood was flowing back into the catheter and also noticed generation of haemaglobin urea.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the angiojet drawer assembly was received in good condition with no physical damages observed.The drawer was installed into ultra system test fixtures and failed 4.26 test steps.The user interface controller showed no error but the unit failed power pulse test with the roller pump pressure below the specifications.Not enough grip on the tubing causes the backflow of blood fluid into the catheter therefore the clinical observation was confirmed.

• 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: 11426744
• MDR Text Key: 238317714
• Report Number: 2134265-2021-02805
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• 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: 08/10/2021

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
• Device Model Number: 45043
• Device Catalogue Number: 45043
• Device Lot Number: U8620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other