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

Model Number 3256

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

It was reported that the rotapro console was operating with erratic speeds and displaying incorrect speeds.The rotapro console selected for use.During the procedure, the device was operating at a much higher speed than the platform speed.The console was displaying a speed that was different than it sounded.No patient complications were reported and the atherectomy portion of the procedure was not able to be performed.

Event Description

It was reported that the rotapro console was operating with erratic speeds and displaying incorrect speeds.The rotapro console selected for use.During the procedure, the device was operating at a much higher speed than the platform speed.The console was displaying a speed that was different than it sounded.No patient complications were reported and the atherectomy portion of the procedure was not able to be performed.

Manufacturer Narrative

The rotapro console was returned for analysis missing the speed control knob.A spare speed control knob was installed.The device passed calibration and full functional testing.The fault condition could not be replicated.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10634613
• MDR Text Key: 210004332
• Report Number: 2134265-2020-13726
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

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: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP000176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1