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

Model Number 45043

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Renal Failure (2041)

Event Date 12/20/2022

Event Type  Injury  

Event Description

It was reported that two patients experienced renal failure after use of angiojet.This angiojet ultra system console was used for treatment in two separate cases.The procedures were performed as expected without any product issues or error messages, however, post-procedure both patients have developed renal failure.The medical conditions of the patients were noted as not different than previously treated patients, and the protocol was the same.This facility has performed multiple cases in the past without any issues.Additional information has been requested; however, no further information has been obtained at this time.

Manufacturer Narrative

Device eval in the field: the field service engineer visited the customer site and successfully completed a functional test and safety evaluation on the angiojet ultra system console.The console was properly calibrated and was working as intended.During field service, the hospital indicated that the issue could have been related to a user error during set-up; however, the root cause of the renal failure after use of the angiojet remains unknown.

Event Description

It was reported that two patients experienced renal failure after use of angiojet.This angiojet ultra system console was used for treatment in two separate cases.The procedures were performed as expected without any product issues or error messages, however, post-procedure both patients have developed renal failure.The medical conditions of the patients were noted as not different than previously treated patients, and the protocol was the same.This facility has performed multiple cases in the past without any issues.Additional information has been requested; however, no further information has been obtained at this time.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16294453
• MDR Text Key: 308754600
• Report Number: 2124215-2023-04575
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/15/2023

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: U8942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other