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

Model Number	H80222782001A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventricular Fibrillation (2130); Diminished Pulse Pressure (2606); Reduced Blood Flow (4598)
Date of Event	07/23/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.It was reported that the patient presented with severe chest pain.A rotalink advancer, 1.25 mm rotalink burr and rotawire drive were selected for treatment of the left circumflex (lcx) and left main (lm) arteries.Following rotablation, slow coronary flow was observed.Medications were administered to manage the patients condition.The patients blood pressure progressively declined and the patient experienced cardiac arrest.Direct current defibrillation and cardiopulmonary resuscitation were performed.Despite all efforts, there was no return of spontaneous circulation, no recordable pulse or blood pressure.The patient was declared dead.The official cause of death was slow flow and bradycardia.
Event or Problem Description
It was reported that the patient died.It was reported that the patient presented with severe chest pain.A rotalink advancer, 1.25 mm rotalink burr and rotawire drive were selected for treatment of the left circumflex (lcx) and left main (lm) arteries.Following rotablation, slow coronary flow was observed.Medications were administered to manage the patient's condition.The patients' blood pressure progressively declined, and the patient experienced cardiac arrest.Direct current defibrillation and cardiopulmonary resuscitation were performed.Despite all efforts, there was no return of spontaneous circulation, no recordable pulse or blood pressure.The patient was declared dead.The official cause of death was slow flow and bradycardia.It was further reported that the patient also presented with shortness of breath, dyspnea and chest heaviness.Injections of adrenaline, atropine, calcium gluconate 10 ml and amiodarone 150 mg were administered during the procedure.Intra-aortic balloon pump (iabp) and temporary pacemaker implantation (tpi) support was also provided.Patient was shifted to the critical care unit and place on mechanical ventilation.The patient experienced ventricular tachycardia and ventricular fibrillation.Hypotension and cardiac arrest were also noted as causes of death.
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 patient died.It was reported that the patient presented with severe chest pain.A rotalink advancer, 1.25 mm rotalink burr and rotawire drive were selected for treatment of the left circumflex (lcx) and left main (lm) arteries.Following rotablation, slow coronary flow was observed.Medications were administered to manage the patients condition.The patients blood pressure progressively declined and the patient experienced cardiac arrest.Direct current defibrillation and cardiopulmonary resuscitation were performed.Despite all efforts, there was no return of spontaneous circulation, no recordable pulse or blood pressure.The patient was declared dead.The official cause of death was slow flow and bradycardia.It was further reported that the patient also presented with shortness of breath, dyspnea and chest heaviness.Injections of adrenaline, atropine, calcium gluconate 10 ml and amiodarone 150 mg were administered during the procedure.Intra-aortic balloon pump (iabp) and temporary pacemaker implantation (tpi) support were also provided.Patient was shifted to the critical care unit and place on mechanical ventilation.The patient experienced ventricular tachycardia and ventricular fibrillation.Hypotension and cardiac arrest was also noted as causes of death.
Additional Manufacturer Narrative
Correction: impact codes.With all the available information, boston scientific concludes: device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the cause of the reported event is unknown.The investigation conclusion code of cause not established was selected.No device damages or performance allegations were included within the reported events.A device malfunction could not be confirmed or ruled out due to a lack of allegations and lack of device return.As a device issue could not be confirmed or ruled out, a most likely cause for the reported events could not be determined using the information available.

• Brand Name: RotaLink? Advancer
• 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; business and technology park,; 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: 50073952
• Report Number: 2124215-2026-40682
• Device Sequence Number: 10216894
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)280330(10)38970681
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0038970681
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 03/31/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female