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

Model Number 45038

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled after the patient had been sedated.The target lesion was located in the deep vein of the left lower limb.An angiojet console was used in a thrombectomy procedure.During priming, the system alerted error code 69 on the screen causing the device to malfunction and catheter could not be used.The patient had been sedated.The procedure was cancelled due to this event.No patient complications were reported and patient's status was stable.

Event Description

It was reported that the procedure was cancelled after the patient had been sedated.The target lesion was located in the deep vein of the left lower limb.An angiojet console was used in a thrombectomy procedure.During priming, the system alerted error code 69 on the screen causing the device to malfunction and catheter could not be used.The patient had been sedated.The procedure was cancelled due to this event.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was not received at the complaint investigation for analysis.However, an in field work order was reviewed as part of this investigation.On (b)(6) 2022 the surgeon received an error 69 while preparing for a procedure.A boston scientific field service engineer (fse) waited to get approval to service the console due to the epidemic situation.On july 13th the fse arrived and during the service noticed an error 69.The fse stated that the roller pump needed to be replaced.After replacing the roller pump the pressure calibration could not be completed and the fse suspected the new roller pump to be faulty and ordered another pump.On the 21july 2022 the fse replaced the roller pump, and the device still could not be calibrated due to the console motherboard.The fse found that the roller pump and the motherboard were both faulty.A new roller pump and mother board were installed.A new drawer assembly was installed.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14628638
• MDR Text Key: 294028197
• Report Number: 2134265-2022-06398
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

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: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U8650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG