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

Model Number	3243
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address - (b)(6).
Event or Problem Description
It was reported that burr separation occurred.A 50% to 60% stenosed target lesion was located in the mildly tortuous and severely calcified ostial right coronary artery (rca).A 1.75mm rotapro device was selected for percutaneous coronary intervention (pci) procedure.During rotablation, the burr was suddenly detached from the advancer.The physician used a a non-boston scientific guide extension catheter to press the burr into the wire and the guide catheter.The burr was removed successfully.The procedure was completed successfully with two synergy megatron with optimal expansion in the lesion.No patient harm resulted in relation to this event.
Event or Problem Description
It was reported that burr separation occurred.A 50% to 60% stenosed target lesion was located in the mildly tortuous and severely calcified ostial right coronary artery (rca).A 1.75mm rotapro device was selected for percutaneous coronary intervention (pci) procedure.During rotablation, the burr was suddenly detached from the advancer.The physician used a a non-boston scientific guide extension catheter to press the burr into the wire and the guide catheter.The burr was removed successfully.The procedure was completed successfully with two synergy megatron with optimal expansion in the lesion.No patient harm resulted in relation to this event.It was further reported that the the burr detached from the shaft.The rotapro was prepped and platformed 160,000rpm outside the patient.During procedure, the burr rotation speed was at 160,000rpm.The burr was removed with the pull of the rotawire.
Additional Manufacturer Narrative
E1: initial reporter address - (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address - (b)(6).Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The device was received with the burr separated and on the rotawire.A non-bsc guideliner was returned with the device in accordance with the reported events.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil had been stretched at the point of detachment from the burr and that the burr had detached and was received on the returned rotawire.X-ray inspection of the device was performed and it was found that the tri-filar coil separated near the proximal end of the burr.Therefore, it was considered likely that the separation did not occur as a result of a glue bond failure within the burr.Product analysis confirmed the reported event, as the burr was received detached from the coil, and the coil was stretched and broken at the point of detachment.
Event or Problem Description
It was reported that burr separation occurred.A (b)(4) stenosed target lesion was located in the mildly tortuous and severely calcified ostial right coronary artery (rca).A 1.75mm rotapro device was selected for percutaneous coronary intervention (pci) procedure.During rotablation, the burr was suddenly detached from the advancer.The physician used a non-boston scientific guide extension catheter to press the burr into the wire and the guide catheter.The burr was removed successfully.The procedure was completed successfully with two synergy megatron with optimal expansion in the lesion.No patient harm resulted in relation to this event.It was further reported that the burr detached from the shaft.The rotapro was prepped and platformed (b)(4) outside the patient.During procedure, the burr rotation speed was at (b)(4).The burr was removed with the pull of the rotawire.

• 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: 15200442
• Report Number: 2124215-2022-29968
• Device Sequence Number: 2239633
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0028413059
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 09/15/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/25/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown