MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; catheter, coronary, atherectomy

Model Number	H749394671500
Medical Device Problem Codes	Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a conference that device detachment and patient complications occurred requiring additional intervention.The patient presented with ischemic heart disease.The chronic total occlusion (cto) target lesion was located in the calcified mid left anterior descending (lad) artery.The lesion was crossed using wire escalation technique and a rotawire was exchanged and inserted into the distal lad.A 1.50 mm rotapro was introduced to ablate the calcified cto, however after a long time rotablating, the lesion could not be crossed.The physician tried at high speed - 200k rpm and on advancement the burr continued in a straight line (not in the pathway of the rotawire).The rotawire had snapped at the point of the calcified lesion and the rotaburr advanced without wire support and perforated the lad wall and went into the pericardial sac.The rotawire and rotaburr were removed, and pericaridocentesis was performed.The perforation was treated with a covered stent, and the distal vessel was embolised using a coil.The patient was stable after the procedure.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.

• 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 ; +1(763)494-1632
• MDR Report Key: 50682512
• Report Number: 2124215-2026-48070
• Device Sequence Number: 14772204
• Product Code: MCX
• UDI-Device Identifier: 08714729999577
• UDI-Public: (01)08714729999577
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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 Model Number: H749394671500
• Device Catalogue Number: H749394671500
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown