MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT; CATHETER, CORONARY, ATHERECTOMY

Model Number	3240
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the speed was too high.A rotablator rotational atherectomy system console kit was selected for use.During the procedure, it was noted that the rotablator is not functioning properly.When it was connected to the gas and set to the optimal range, the speed was too high and is unable to be turned back down.There were no patient complications reported.
Event or Problem Description
It was reported that the speed was too high.A rotablator rotational atherectomy system console kit was selected for use.During the procedure, it was noted that the rotablator is not functioning properly.When it was connected to the gas and set to the optimal range, the speed was too high.There were no patient complications reported.It was further reported that the knob on the console would not properly adjust the rpms.The regulator was adjusted to get the device to platform properly.
Additional Manufacturer Narrative
The rotablator console was returned for analysis with a broken warranty label but in otherwise good condition.Functional testing revealed the pressure gauge did not display between 83-87 psi and the rpm displayed 156,000 rather than between 83,000 and 120,000.
Event or Problem Description
It was reported that the speed was too high.A rotablator rotational atherectomy system console kit was selected for use.During the procedure, it was noted that the rotablator is not functioning properly.When it was connected to the gas and set to the optimal range, the speed was too high.There were no patient complications reported.It was further reported that the knob on the console would not properly adjust the rpms.The regulator was adjusted to get the device to platform properly.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13979751
• Report Number: 2134265-2022-03760
• Device Sequence Number: 17502837
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 3240
• Device Catalogue Number: 3240
• Device Lot Number: RC402887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 06/13/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/12/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown