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

Model Number	39467-150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - (b)(6).
Event or Problem Description
It was reported that a burr detachment occurred.A 1.50 mm rotapro was selected for use.During the procedure, it was noted that the burr got separated.The lesion area was dilated with a balloon catheter, and the burr was retrieved inside the guiding catheter with a snare.No fragments remained inside the body.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that a burr detachment occurred.A 1.50 mm rotapro was selected for use.During the procedure, it was noted that the burr got separated.The lesion area was dilated with a balloon catheter, and the burr was retrieved inside the guiding catheter with a snare.No fragments remained inside the body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter city: (b)(6).Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the coil was stretched and detached.No other issues were identified during the product analysis.

• 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: 20514593
• Report Number: 2124215-2024-65908
• Device Sequence Number: 17919816
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 09/04/2026
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0034774281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown