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

Model Number	39467-225
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 23aug2024.It was reported that the burr could not pass through the guide catheter tip section.A 2.25mm rotapro was selected for use.During the procedure, it was noted that the burr could not pass through the guide catheter tip.The device was removed by normal extraction method.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the coil and sheath were detached on the proximal end of the burr catheter at 82cm.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found that the coil and sheath were detached on the proximal end of the burr catheter.Total returned length was 82cm.The detached ends appeared sharp and jagged in nature as if to indicate the device was cut.The burr housing portion of the device failed to return for further analysis.As the guide catheter used in the procedure was not returned for analysis, a test guide catheter of at least 0.093" was used for functional testing per the guide catheter sizing chart within the instructions for use.The burr portion was inserted into the hub of the guide catheter and advanced through the guide catheter up until the separated end of the burr catheter with no resistance or issues.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20226186
• Report Number: 2124215-2024-55070
• Device Sequence Number: 3470030
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/16/2024

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: 09/11/2025
• Device Model Number: 39467-225
• Device Catalogue Number: 39467-225
• Device Lot Number: 0032407259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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