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

Model Number	3243
Medical Device Problem Codes	Difficult to Remove (1528); 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	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.
Event or Problem Description
It was reported that device detachment occurred.A rotapro 1.75mm atherectomy catheter was selected for coronary treatment.Catheter separation was observed resulting in the rotawire laying freely within the vessel.Retrieval of the rotapro 1.75mm atherectomy catheter was difficult.The rotapro 1.75mm atherectomy catheter was fully retrieved and withdrawn from the patient.No patient complications reported and the procedure was completed with another rotapro 1.75mm.
Additional Manufacturer Narrative
B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The rotawire used in the procedure was also retuned.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the sheath was torn at 29cm from the burr housing strain relief and that the coil was stretched at the point of tearing.Product analysis confirmed the reported event, as the sheath was torn, and the coil was stretched at the point of tearing.
Event or Problem Description
It was reported that device detachment occurred.A rotapro 1.75mm atherectomy catheter was selected for coronary treatment.Catheter separation was observed resulting in the rotawire laying freely within the vessel.Retrieval of the rotapro 1.75mm atherectomy catheter was difficult.The rotapro 1.75mm atherectomy catheter was fully retrieved and withdrawn from the patient.No patient complications reported and the procedure was completed with another rotapro 1.75mm.

• 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: 15617221
• Report Number: 2124215-2022-41822
• Device Sequence Number: 20354260
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/03/2023

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: 06/28/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0029676085
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown