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

Model Number	3360
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was rescheduled.A target lesion was located in the severely calcified artery.A ce rotablator was selected for use.During the procedure, the dynaglide foot pedal was not working.The procedure was rescheduled.Three days later, the procedure completed with another device.There were no patient complications reported.
Event or Problem Description
It was reported that the procedure was rescheduled.A target lesion was located in the severely calcified artery.A ce rotablator was selected for use.During the procedure, the dynaglide foot pedal was not working.The procedure was rescheduled.Three days later, the procedure completed with another device.There were no patient complications reported.It was further reported that the patient was sedated with local anesthesia.

• Brand Name: ROTABLATOR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19067270
• Report Number: 2124215-2024-20345
• Device Sequence Number: 6676952
• Product Code: MCX
• UDI-Device Identifier: 08714729353317
• UDI-Public: 08714729353317
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121774
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 3360
• Device Catalogue Number: 3360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: Asian