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

Model Number 3256

Device Problem Unstable (1667)

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

Event Date 11/10/2020

Event Type  malfunction  

Event Description

It was reported that rotation speed was erratic.A rotapro console was selected for an atherectomy procedure.During the procedure, the rotation speed fluctuated and rpms could not be maintained.The procedure was completed with this device.No patient complications were reported, and the patient is in good condition post-procedure.

Event Description

It was reported that rotation speed was erratic.A rotapro console was selected for an atherectomy procedure.During the procedure, the rotation speed fluctuated and rpms could not be maintained.The procedure was completed with this device.No patient complications were reported, and the patient is in good condition post-procedure.

Manufacturer Narrative

Device eval by manufacturer: the rotapro console serial number (b)(6) was returned.The console was returned in overall good physical condition.The unit passed all incoming functional tests.Unable to replicate the fault condition.The rotapro passed calibration and full functional final testing.

• 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: 10935745
• MDR Text Key: 219197933
• Report Number: 2134265-2020-16761
• 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: 03/17/2021

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: RP001588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/17/2021
• Patient Sequence Number: 1