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

Model Number	3243
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire fractured and the procedure was cancelled.A rotapro 1.75mm was being used for treatment.During preparation for the procedure, the physician noted that the advancer knob was unable to be moved.They attempted to screw and unscrew the knob multiple times, but the advancer knob was still unable to be moved.Upon inspection the physician also noted that there was a white cable that was blocking the path of the advancer knob.The device was replaced with another rotapro, however there were difficulties in loading the burr on to the rotawire.The rotawire was thought to be broken within the advancer of the second rotapro.Due to the issues with these three devices, the procedure was unable to be completed at that time.The sedation status of the patient is unknown.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by toggling/moving the advancer knob back and forth.When toggled, there was no resistance and the advancer knob moved smoothly.The white cable identified within the reported events did not impact the ability of the advancer knob to move back and forth during testing.Product analysis did not confirm the reported event, as the advancer knob was able to be toggled with no resistance.
Event or Problem Description
It was reported that a guidewire fractured and the procedure was cancelled.A rotapro 1.75mm was being used for treatment.During preparation for the procedure, the physician noted that the advancer knob was unable to be moved.They attempted to screw and unscrew the knob multiple times, but the advancer knob was still unable to be moved.Upon inspection the physician also noted that there was a white cable that was blocking the path of the advancer knob.The device was replaced with another rotapro, however there were difficulties in loading the burr on to the rotawire.The rotawire was thought to be broken within the advancer of the second rotapro.Due to the issues with these three devices, the procedure was unable to be completed at that time.The sedation status of the patient is unknown.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14835511
• Report Number: 2134265-2022-07338
• Device Sequence Number: 4832584
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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 Expiration Date: 02/19/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026839396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown