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

Model Number	3243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Myocardial Infarction (1969); Reduced Blood Flow (4598)
Date of Event	02/18/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported a patient death occurred.During the procedure in the right coronary artery (rca), ostium subtotal, the lesion was moderately tortuous, severely calcified and 90% stenosed.A 6f guiding catheter was selected for treatment , and then replaced with a 7f catheter.Initially a non-boston scientific wire was used, then changed to a rotawire floppy via a microcatheter, along with a 1.75 mm rotapro.Four runs of rotational atherectomy were conducted, each about 20 seconds, with a maximum rpm drop of 15 k.However, no reflow occurred, leading to balloon angioplasty and implantation of two stents.There was no antegrade flow observed in the coronary artery (no timi flow), causing av block, and requiring a temporary pacemaker.Complications that were encountered included myocardial infarction/ischemia and further interventions included administration of isoprel, agostat, katechomalin, atropin, and use of a temporary pacemaker.Following the procedure, the patient was transferred to the critical care unit (ccu).Though no device malfunctions occurred, the physician is unsure if the device or procedure contributed to the complications.However, further information confirmed death of the patient on an unknown date.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21572780
• Report Number: 2124215-2025-14604
• Device Sequence Number: 18229571
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/11/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031280523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 03/22/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown