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

Model Number	3320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Arrhythmia (1721); Bradycardia (1751); Myocardial Infarction (1969); Vasoconstriction (2126); Vasospasm (2128); Obstruction/Occlusion (2422); Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446); Unspecified Heart Problem (4454); Reduced Blood Flow (4598)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: earliest possible date of event as the patients underwent ra from july 2021 - june 2023 detailed product information was not provided to bsc, because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.Liu x, wan l, liu y, gu y and hu l (2025) planned vs.Rescue rotational atherectomy in severe coronary calcification: procedural complications and one-year clinical outcomes.Front.Cardiovasc.Med.12:1599091.Doi: 10.3389/fcvm.2025.1599091.
Event or Problem Description
It was reported via literature article that patient complications occurred.Current guidelines recommend rotational atherectomy (ra) as a rescue treatment for calcified or fibrotic lesions that cannot be fully expanded before stent implantation.Present study compared the procedural and one-year clinical outcome of planned (pra) or rescue ra (rra) for patients undergoing percutaneous coronary intervention with severe coronary stenosis and calcification.A total of 111 consecutive patients who underwent ra at the fourth hospital of wuhan from july 2021 to june 2023 were enrolled.Percutaneous coronary intervention was performed through the radial artery, brachial artery or femoral artery, and unfractionated heparin 70 to 100 u/kg was given before pci.The boston scientific rotablator tm was used for ra, and the ra head was rota link tm (diameters: 1.25 mm, 1.50 mm, and 1.75 mm, respectively).The size of the ra head was selected to have a ratio of 0.5 to 0.6 between the ra head diameters and the vessel diameter, and the ra speed was 140,000 to 160,000 rpm, and each ra lasted 10 to 15 s.During ra, continuous intracoronary infusion of a mixture containing unfractionated heparin and nitroglycerin was used.The success of ra was defined as complete balloon dilatation of the target lesion after ra.Before ra, all patients received 300 mg aspirin and an oral loading dose of a p2y12 inhibitor (clopidogrel or ticagrelor).At discharge, all patients received aspirin (100 mg daily) plus clopidogrel (75 mgdaily) or ticagrelor (90 mg twice daily) for at least 1 year.According to the timing of initiation of ra, patients were stratified into pra group (n = 84) or rra group (n = 27).Baseline clinical characteristics were similar between the two groups.The number of stents implanted was similar in the two groups.The rra group required more pre dilation balloons (1.7 0.7 vs.3.4 0.5, p < 0.001), exhibited a higher rate of coronary artery dissection (29.6% vs.7.1%, p = 0.02) and consumed a larger volume of contrast (189.8 59 ml vs.139.9 46 ml, p < 0.001).Additionally, the incidence of contrast induced nephropathy was significantly greater in the rra group (29.6% vs.9.5%, p = 0.01), and the procedure duration was markedly longer in this group compared to the pra group (91.5 24.3 min vs.77.9 25.2 min, p < 0.001).Multivariable logistic regression identified rra as an independent predictor of periprocedural complications (adjusted or = 2.83; 95% ci:1.01 to 7.99; p = 0.048).Perioperative complications included coronary artery dissection, coronary artery spasm, slow flow and no reflow, severe bradycardia, side branch occlusion and periprocedural myocardial infarction, contrast-induced nephropathy and the incidence of major adverse cardiovascular and cerebrovascular events (macce) during hospitalization and macce 1 year after pci, secondary endpoints include unstable angina, arrythmia, heart failure and cardiovascular readmission.
Event or Problem Description
It was reported via literature article that patient complications occurred.Current guidelines recommend rotational atherectomy (ra) as a rescue treatment for calcified or fibrotic lesions that cannot be fully expanded before stent implantation.Present study compared the procedural and one-year clinical outcome of planned (pra) or rescue ra (rra) for patients undergoing percutaneous coronary intervention with severe coronary stenosis and calcification.A total of 111 consecutive patients who underwent ra at (b)(6) hospital of from (b)(6) 2021 to (b)(6) 2023 were enrolled.Percutaneous coronary intervention was performed through the radial artery, brachial artery or femoral artery, and unfractionated heparin 70 to 100 u/kg was given before pci.The boston scientific rotablator tm was used for ra, and the ra head was rota link tm (diameters: 1.25 mm, 1.50 mm, and 1.75 mm, respectively).The size of the ra head was selected to have a ratio of 0.5 to 0.6 between the ra head diameters and the vessel diameter, and the ra speed was 140,000 to 160,000 rpm, and each ra lasted 10 to 15 s.During ra, continuous intracoronary infusion of a mixture containing unfractionated heparin and nitroglycerin was used.The success of ra was defined as complete balloon dilatation of the target lesion after ra.Before ra, all patients received 300 mg aspirin and an oral loading dose of a p2y12 inhibitor (clopidogrel or ticagrelor).At discharge, all patients received aspirin (100 mg daily) plus clopidogrel (75 mgdaily) or ticagrelor (90 mg twice daily) for at least 1 year.According to the timing of initiation of ra, patients were stratified into pra group (n = 84) or rra group (n = 27).Baseline clinical characteristics were similar between the two groups.The number of stents implanted was similar in the two groups.The rra group required more pre dilation balloons (1.7 0.7 vs.3.4 0.5, p < 0.001), exhibited a higher rate of coronary artery dissection (29.6% vs.7.1%, p = 0.02) and consumed a larger volume of contrast (189.8 59 ml vs.139.9 46 ml, p < 0.001).Additionally, the incidence of contrast induced nephropathy was significantly greater in the rra group (29.6% vs.9.5%, p = 0.01), and the procedure duration was markedly longer in this group compared to the pra group (91.5 24.3 min vs.77.9 25.2 min, p < 0.001).Multivariable logistic regression identified rra as an independent predictor of periprocedural complications (adjusted or = 2.83; 95% ci:1.01 to 7.99; p = 0.048).Perioperative complications included coronary artery dissection, coronary artery spasm, slow flow and no reflow, severe bradycardia, side branch occlusion and periprocedural myocardial infarction, contrast-induced nephropathy and the incidence of major adverse cardiovascular and cerebrovascular events (macce) during hospitalization and macce 1 year after pci, secondary endpoints include unstable angina, arrythmia, heart failure and cardiovascular readmission.
Additional Manufacturer Narrative
Investigation results: device history review: a review was not completed of the device history records (dhr) for the device.The dhr review cannot be performed as no batch number was reported and a ship history cannot be performed since the upn was not reported.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.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 and the corresponding labeling, the reported allegation is a well-known risk related to the use of the device or the procedure.The investigation conclusion code of known inherent risk of device was selected.B3 date of event: earliest possible date of event as the patients underwent ra from (b)(6) 2021 - (b)(6) 2023.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25035185
• Report Number: 2124215-2026-23258
• Device Sequence Number: 21126066
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: (01)08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 3320
• Device Catalogue Number: 3320
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/04/2026
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown