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

Model Number	3256
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2021.
Event or Problem Description
It was reported that the console displayed inaccurate and unstable rotation speeds.A rotapro console was selected for use in an atherectomy procedure.During ablation inside the patient, the console showed random and faulty rotation speeds.The displayed speeds kept jumping above and below the set speed.No patient complications were reported.
Event or Problem Description
It was reported that the console displayed inaccurate and unstable rotation speeds.A rotapro console was selected for use in an atherectomy procedure.During ablation inside the patient, the console showed random and faulty rotation speeds.The displayed speeds kept jumping above and below the set speed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a rotapro console.Visual examination of the device showed no physical damage.The console passed full functional tests and unable to replicate the fault condition.Inspection of the remainder of the device, revealed no other damage or irregularities.B3: date of event - event date was not reported and was approximated to (b)(6) 2021.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11345087
• Report Number: 2134265-2021-01948
• Device Sequence Number: 14701867
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP001637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1