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

Model Number 45038

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1:(b)(6).

Event Description

It was reported that the procedure was cancelled.The target lesion was located in the left iliofemoral vein.An angiojet ultra system console was selected for use in a thrombectomy procedure.However, during the preparation, an error 50 was displayed.Due to this event the procedure was called off.No patient complications were reported, and the patient's status was stable.

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that the procedure was cancelled.An angiojet ultra system console was selected for use in a thrombectomy procedure.Before the procedure, the system displayed a power error code 50.Due to this event the procedure was cancelled.No patient complications were reported, and the patient's status was stable.However, it was further reported that the patient was sedated with local anesthesia, and the procedure was completed with another method.

• Brand Name: ANGIOJET ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18144625
• MDR Text Key: 328504692
• Report Number: 2124215-2023-63406
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U8662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 74 KG