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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a burr detachment occurred and became stuck with the guidewire.A 1.50mm rotapro was selected for use for a percutaneous coronary intervention procedure.During preparation, it was noted that the drill head of the 1.50mm rotapro came loose and detached from the shaft of the device when it was threaded onto the guidewire.The 1.50mm rotapro drill head remained on the guidewire.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Correction: h6 device code - removal of entrapment of device code as review determined it was inadvertently added.Device evaluated by manufacturer: the returned product consisted of the rotapro atherectomy device.The device was received with the burr separated.The burr was received on the returned rotawire.The advancer, drive shaft, handshake connections, housing, sheath, coil, and burr 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 was detached from the coil.The product analysis confirmed the reported event, as the burr was received detached from the coil, and the coil was stretched at the point of detachment.
Event or Problem Description
It was reported that a burr detachment occurred and became stuck with the guidewire.A 1.50mm rotapro was selected for use for a percutaneous coronary intervention procedure.During preparation, it was noted that the drill head of the 1.50mm rotapro came loose and detached from the shaft of the device when it was threaded onto the guidewire.The 1.50mm rotapro drill head remained on the guidewire.The procedure was completed with another of the same device.No patient complications were 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17338158
• Report Number: 2124215-2023-37670
• Device Sequence Number: 6477781
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• 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): 08/14/2023

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: 04/20/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031471699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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