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

Model Number	3243
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found no damages or defects.During analysis of the returned device, the fiber optic connector was thoroughly examined and no damages or defects to the fiber optic cables, or connector housing were noted.Functional testing was then performed by connecting the advancer to the rotapro control console.When connecting the fiber optic housing to the rotapro console, there were no difficulties or abnormalities noted with the connection.During functional testing, the device was able to reach and maintain optimal rpm in both normal and dynaglide modes with no issues or abnormally high displayed rpm.The rotation speed displayed consistently between 190,000 rpm to 193,0000 rpm.Product analysis did not confirm the reported event, as the device was able to reach and maintain optimal rpm with no issues or abnormally high displayed rpm and clinical circumstances were unable to be replicated.
Event or Problem Description
It was reported that unstable speed occurred.A 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.75mm rotapro was selected for percutaneous coronary intervention (pci).During the procedure, the rotation speed was set to 190,000 rpm.However, when the position of the burr was returned to the platform inside the body at the end of the ablation, it was noted that the rotation speed increased to a maximum of 310,000 rpm.After removing the burr from the patient without using dynaglide mode, the rotawire was also removed from the body to check for any abnormalities in appearance.Both burr and wire did not show any appearance abnormalities.The procedure was completed successfully with another 2.0 mm rotapro device.There were no patient complications reported.

• 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 SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16856131
• Report Number: 2124215-2023-20737
• Device Sequence Number: 6865690
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• 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
• Report Date (Section B): 05/02/2023

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: 08/06/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0027793254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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