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

Model Number 3360

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Event 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 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
• Type of Device: 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
• MDR Text Key: 339807580
• Report Number: 2124215-2024-20345
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729353317
• UDI-Public: 08714729353317
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3360
• Device Catalogue Number: 3360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: Asian