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

Model Number	39467-125
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Codes	Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 initial reporter email: (b)(6).
Event or Problem Description
It was reported that the burr became stuck in lesion, guidewire detachment occurred, requiring additional intervention.The target lesion was located in the severely calcified right coronary artery.A 1.25mm rotapro and rotawire were selected for use.During the procedure, after reaching the lesion, rotablation was performed but was ineffective as burr became stuck in lesion.The burr was removed as a system, mother-in-child system technique, but the rotawire breaks downstream of the burr.At the end of the procedure, coronary dissection at the level of the occlusion with a 2 cm pericardial effusion was noted and pericardiocentesis was performed.
Additional Manufacturer Narrative
B5 describe event or problem: updated.H6 device code: updated.E1 initial reporter email: (b)(6).
Event or Problem Description
It was reported that the burr became stuck in lesion, guidewire detachment occurred, requiring additional intervention.The target lesion was located in the severely calcified right coronary artery.A 1.25mm rotapro and rotawire were selected for use.During the procedure, after reaching the lesion, rotablation was performed but was ineffective as burr became stuck in lesion.The burr was removed as a system, mother-in-child system technique, but the rotawire breaks downstream of the burr.At the end of the procedure, coronary dissection at the level of the occlusion with a 2 cm pericardial effusion was noted and pericardiocentesis was performed.It was further reported that burr stall after a few seconds from the start of rotation.

• 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: 20462785
• Report Number: 2124215-2024-64692
• Device Sequence Number: 8701386
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 11/05/2024

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: 07/16/2026
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0034444641
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 07/16/2024
• 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 Age: 74 YR
• Patient Sex: Unknown