MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Model Number 45043

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.It was further reported that error 69 and 43 occurred.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.It was further reported that error 69 and 43 occurred.

Manufacturer Narrative

Device evaluated by mfr: angiojet drawer was received.The drawer was decontaminated.A visual inspection was done on the drawer, and it failed because it is missing 2 screws.Then a functional test was done on the drawer.It passed the functional test.

Manufacturer Narrative

Device evaluated by mfr: angiojet console (b)(6) was also received and decontaminated.The console failed visual inspection because one of the bag holder assemblies was broken.Then a functional test was done on the console.It failed the functional test by booting up to error code 56.This resulted in product failure, confirming the complaint.Device evaluated by mfr: angiojet drawer was received.The drawer was decontaminated.A visual inspection was done on the drawer, and it failed because it is missing 2 screws.Then a functional test was done on the drawer.It passed the functional test.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BAYER INTERVENTIONAL; 8880 evergreen blvd; coon rapids MN 55433
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16327693
• MDR Text Key: 309184771
• Report Number: 2124215-2023-04613
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: 08714729890607
• 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: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2023

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: U2535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/10/2023; 03/31/2023; 09/13/2023
• Supplement Dates FDA Received: 03/06/2023; 04/24/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1