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

Model Number	H749394672250
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was stuck in lesion.The 80-90% stenosed target lesion was located in the moderately angulated and severely calcified right coronary artery.A 2.25mm rotapro was selected for use.During the procedure, the burr became stuck in the lesion.Several maneuvers were done in an attempt to free the burr.First, dynaglide was used with traction unsuccessfully.Next, a second wire was advanced past the burr and a balloon was inflated next to the burr followed by traction, which was also unsuccessful.Ultimately, the burr shaft was cut, and a non-boston scientific guide extension catheter was advanced to the burr.The burr was completely removed from the patient body.The procedure was completed using another device and was prolonged resulting in excess of 6 gy of radiation.The patient condition was stable 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21504814
• Report Number: 2124215-2025-11296
• Device Sequence Number: 8007292
• Product Code: MCX
• UDI-Device Identifier: 08714729999614
• UDI-Public: 08714729999614
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2026
• Device Model Number: H749394672250
• Device Catalogue Number: H749394672250
• Device Lot Number: 0033229438
• 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: 02/04/2025
• Initial Report FDA Received Date: 03/03/2025
• Date Device Manufactured: 01/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETER: GUIDELINER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown