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

Model Number 45043

Device Problems Display or Visual Feedback Problem (1184); Failure to Prime (1492)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the procedures were cancelled.An angiojet console was selected for use in two different thrombectomy procedures.During the first procedure, the console stopped priming the catheter and a check saline error message was displayed.The procedure was cancelled due to this event.The same event occurred during the second procedure.The procedure was also cancelled as a result.No patient complications were reported.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr.: the angiojet ultra console was received in clonmel in good condition.The angiojet ultra console powered up but failed the angiojet basic functional test.On visual inspection, the angiojet console was ok, with no scratches or dents.The angiojet console could not complete a priming sequence process , it would show an error saying issue with saline supply, a new catheter was installed and the same issue was showing.There were no kinks in the saline supply and an adequate supply of fluid present.Field reported fault has been confirmed and traced back to a faulty drawer.The drawer was replaced and the angiojet functioned as it should.

Event Description

It was reported that the procedures were cancelled.An angiojet console was selected for use in two different thrombectomy procedures.During the first procedure, the console stopped priming the catheter and a check saline error message was displayed.The procedure was cancelled due to this event.The same event occurred during the second procedure.The procedure was also cancelled as a result.No patient complications were reported.It was further reported that the procedure was completed using a non-bsc device and the patient was not sedated.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13224949
• MDR Text Key: 283607455
• Report Number: 2134265-2021-16441
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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: 45043
• Device Catalogue Number: 45043
• Device Lot Number: U8907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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