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

Model Number	39467-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on the wire.The 78% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.50mm rotapro and rotawire were selected for use.During the procedure, it was noted that the rotapro burr could not be removed as it was stuck on the rotawire.The devices were removed together as one unit.The procedure was completed.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Inspection of the device found that the sheath was kinked at the most proximal end.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and removed from the device with no resistance or issues.
Event or Problem Description
It was reported that the burr was stuck on the wire.The 78% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.50mm rotapro and rotawire were selected for use.During the procedure, it was noted that the rotapro burr could not be removed as it was stuck on the rotawire.The devices were removed together as one unit.The procedure was completed.There were no patient complications reported post procedure.

• 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: 20251457
• Report Number: 2124215-2024-56415
• Device Sequence Number: 8163227
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2026
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0033489649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female