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

Model Number	3243
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the sheath was torn 24cm distal of the burr catheter strain relief.A majority of the coil was found to be stretched, and there was blood found within the sheath and advancer body.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to be rotated with no issue.Then functional testing was performed by connecting the rotapro advancer to the rotapro control console system.When the knob ablation switch was pressed, the device stalled and would not run.Destructive testing was performed, in which the advancer was dismantled and the interior components within the advancer were inspected.Inspection of the interior components did not find any damages or defects attributable to the stall.Product analysis confirmed the reported events, as the device stalled and would not run.It is likely that the presence of blood within the sheath and advancer is indicative of a lack of sufficient saline flow through the device, which is attributable to the device stall.
Event or Problem Description
Reportable based on device analysis completed (b)(6) 2022.It was reported that a stall occurred.A rotapro 1.75mm was selected for use to treat an 85% stenosed moderately calcified non-tortuous target lesion within the right coronary artery.After successful atherectomy, the device stalled while in dynaglide mode as the rotapro 1.75mm was being withdrawn from the patient.The physician turned dynaglide off and was able to remove the burr successfully and intact.The rotapro 1.75mm was removed successfully intact without the use of dynaglide.The procedure was completed with no patient complications.However device analysis revealed a torn sheath.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13543041
• Report Number: 2134265-2022-01737
• Device Sequence Number: 14501859
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/16/2022

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: 08/13/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0027834235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male