MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number 39467-150

Device Problem Output Problem (3005)

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

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported that the speed was unstable.A 1.50mm rotapro was selected for use.During the procedure, it was noted that the device would not communicate with the controller or lower the rpm.The procedure was completed with a different device.There were no patient complications reported post procedure.

Manufacturer Narrative

The device was returned and evaluated by manufacturer.Visual inspection of the device did not identify any damages or defects.After destructive testing was performed, it was found that the turbine was corroded, indicating the presence of dried saline within the device.It was considered likely that the presence of dried saline interfered with the devices ability to rotate during analysis, leading to a device stall.There were no other damages or defects identified during destructive testing that would be considered attributable to the reported unstable speed.During device-to-device interaction, when the rotapro advancer was connected to the rotapro console control system and the knob switch or ablation button was pressed, the device stalled and would not run.

Event Description

It was reported that the speed was unstable.A 1.50mm rotapro was selected for use.During the procedure, it was noted that the device would not communicate with the controller or lower the rpm.The procedure was completed with a different device.There were no patient complications reported post procedure.

• Brand Name: ROTAPRO
• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19209476
• MDR Text Key: 341370273
• Report Number: 2124215-2024-24811
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0033243910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1