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

Model Number	39467-175
Medical Device Problem Codes	Entrapment of Device (1212); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on wire.A 1.75mm rotapro and rotawire drive were selected for use.During the procedure, the rotation speed was not stable, and it only increases for about 5000 rpm.Consecutively, the wire got stuck with the burr during dynaglide mode.The device was removed together from the patient.The procedure was completed with another of same device.No complications were reported, and patient was good after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device did not identify any damages or defects.Inspection of the device after destructive testing found that the turbine was corroded.It was considered likely that the corrosion to the device identified during analysis was caused by the drying of the saline infusion that had been used during the procedure.As the rotawire used in the procedure was not returned a test wire was used for analysis.During analysis, the rotawire was able to be removed and fully reinserted into the device with no resistance or issues.The rotapro advancer was connected to the rotapro control console system.The device stalled and would not run.In order to determine the reason for the device stall, the advancer was dismantled and the components inside the advancer were inspected.After destructive testing was performed, it was found that the shutter was damaged.The damage present could lead to fiberoptic interference.
Event or Problem Description
It was reported that the burr was stuck on wire.A 1.75mm rotapro and rotawire drive were selected for use.During the procedure, the rotation speed was not stable, and it only increases for about 5000 rpm.Consecutively, the wire got stuck with the burr during dynaglide mode.The device was removed together from the patient.The procedure was completed with another of same device.No complications were reported, and patient was good after the procedure.

• Brand Name: ROTAPRO
• Common Device Name: 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: 20481763
• Report Number: 2124215-2024-65255
• Device Sequence Number: 8275841
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2026
• Device Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0034113722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown