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

Model Number	H749394672000
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Material Separation (1562); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the burr got stuck and separated.The 90% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery.A 1.50mm rotapro and 2.0mm rotapro were selected for use.During the procedure, with doctor aoyama, a 1.5mm rotapro was advance at 180,000rpm.However, upon five sessions, the speed has reduced to 2,000rpm and the advancer move all the way to the right and stopped within the calcified area without completely crossing the lesion with the speed continuously dropping.The device was pulled gently on the proximal part up to the guide, but resistance was felt upon insertion.Imaging shows the burr remained and got separated.Since the wire was not cut, the device was removed by simply pulling the wire out.Doctor (b)(6) changed the burr size to 2.0mm rotapro and was advanced to 180,000rpm until seven session and lower down to 6,000rpm.Upon increasing the ablation, the burr got completely struck at the stenosis site after 1,000rpm drop.Since this part was near the ostium part, the burr was pulled proximally at the same time with the guide.However, a severe resistance was felt when pulled within the guide and got separated.It was confirmed that only the tip of rota was separated in a shape that the head has come off.Since there were no damage within the blood vessel and wire, the procedure continued and completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
H6 device code: updated.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device noted that majority of the coil was stretched from the handshake connection to the distal end of the coil which was detached.The returned rotawire failed to be removed and was frozen due to the coil damage present.The wire contained the detached burr which was moveable.
Event or Problem Description
It was reported that the burr got stuck and separated.The 90% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery.A 1.50mm rotapro and 2.0mm rotapro were selected for use.During the procedure, with doctor aoyama, a 1.5mm rotapro was advance at 180,000rpm.However, upon five sessions, the speed has reduced to 2,000rpm and the advancer move all the way to the right and stopped within the calcified area without completely crossing the lesion with the speed continuously dropping.The device was pulled gently on the proximal part up to the guide, but resistance was felt upon insertion.Imaging shows the burr remained and got separated.Since the wire was not cut, the device was removed by simply pulling the wire out.Doctor miyazaki changed the burr size to 2.0mm rotapro and was advanced to 180,000rpm until seven session and lower down to 6,000rpm.Upon increasing the ablation, the burr got completely struck at the stenosis site after 1,000rpm drop.Since this part was near the ostium part, the burr was pulled proximally at the same time with the guide.However, a severe resistance was felt when pulled within the guide and got separated.It was confirmed that only the tip of rota was separated in a shape that the head has come off.Since there were no damage within the blood vessel and wire, the procedure continued and completed with another of the same device.No patient complications reported.

• 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: 23310863
• Report Number: 2124215-2025-72016
• Device Sequence Number: 5789204
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)270624(10)36827289
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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 Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0036827289
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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: 0.014 ROTAWIRE EXTRA SUPPORT; 0.014 ROTAWIRE EXTRA SUPPORT; 8FR SAL1.0 SH HYPERION; 8FR SAL1.0 SH HYPERION; IVUS -IMAGING; IVUS -IMAGING
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 77 KG