MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number 3240

Device Problems Failure to Power Up (1476); Premature Activation (1484); Intermittent Loss of Power (4016)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.A 1.25mm rotalink plus and a 330cm rotawire were selected for use.During the procedure, after a connection was made with the rotalink plus, the rotablator console, no longer functioned as expected.The light on the device displayed power on, however the device continued to turn off.Additionally, a stall message was displayed whenever the pedal was pressed to test the rotations.The procedure was not completed due to this event.There were no patient complications reported post procedure.

Manufacturer Narrative

This correction smdr is being submitted to update the as reported-device code from failure to power-up to system start up issue.

Event Description

It was reported that the procedure was cancelled.A 1.25mm rotalink plus and a 330cm rotawire were selected for use.During the procedure, after a connection was made with the rotalink plus, the rotablator console, no longer functioned as expected.The light on the device displayed power on, however the device continued to turn off.Additionally, a stall message was displayed whenever the pedal was pressed to test the rotations.The procedure was not completed due to this event.There were no patient complications reported post procedure.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18021995
• MDR Text Key: 326740460
• Report Number: 2124215-2023-57329
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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: 3240
• Device Catalogue Number: 3240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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