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

Model Number 3240

Device Problems Unstable (1667); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.A rotablator rotational atherectomy system console kit was selected for use in a rotational atherectomy procedure.During the procedure, the rotalink plus was connected and the rotation speed was adjusted.However, there was no response from the equipment to the speed adjustment of the control knob leading to high revolutions without control.The procedure was unsuccessful and was cancelled.No patient complications complications were reported.

Event Description

It was reported that the procedure was cancelled.A rotablator rotational atherectomy system console kit was selected for use in a rotational atherectomy procedure.During the procedure, the rotalink plus was connected and the rotation speed was adjusted.However, there was no response from the equipment to the speed adjustment of the control knob leading to high revolutions without control.The procedure was unsuccessful and was cancelled.No patient complications were reported.It was further reported that the operating speed is set according to the size of the burr; a set speed does not come by default.The maximum speed reached is 260 rate per minute (rpm).The operating speed could not be established as the equipment did not respond to the rpm setting.To complete the procedure, high pressure balloons were used to modify the plate and implant the stent.The patient is stable and on medical discharge.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10489280
• MDR Text Key: 205529340
• Report Number: 2134265-2020-12234
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (y/n): N
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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
• Device Lot Number: RC109006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 78