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	Atrial Fibrillation (1729); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Vascular Dissection (3160); Reduced Blood Flow (4598)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dissection, slow blood flow and arrythmia occurred and the patient expired.The patient was elderly, with triple-vessel coronary artery disease and was considered high-risk with complex lesions.Coronary artery bypass grafting (cabg) surgery was recommended half a month prior.The patient was admitted to the hospital on (b)(6) 2025 requesting percutaneous coronary intervention (pci).The doctor, physician, and the hospital medical affairs department had thorough communication and informed the family of the high risks involved.Access was obtained via the right radial artery.Angiography and opticross intravascular ultrasound (ivus) both revealed 99% stenosis, severely calcified lesions in the mid-proximal segment in the right coronary artery (rca).Additionally, diffuse calcified lesions with 80-90% stenosis were observed in the mid-proximal segment of the left anterior descending artery (lad) and diffuse calcified lesions with 99% stenosis in the diagonal branch.Diffuse calcified lesions with 80-90% stenosis were also noted in the mid-proximal segment of the left circumflex artery (lcx).A 2.0 x 20mm maverick balloon was inflated at 12 atmospheres (atm) to dilate the rca lesion, showing a significant waist sign on the balloon.Ivus revealed diffuse 360-degree circumferential calcification in the rca, with a minimum lumen diameter of 1.3mm.Rotational atherectomy (rota) was then performed in the rca plaque using a boston scientific (bsc) 1.5 mm rotaburr.The burr was rotated four times at 160,000 revolutions per minute (rpm), total 48 seconds, and successfully passed through the lesion.During rotablation, the patient's electrocardiogram (ecg) showed a heart rate drop to 50 beats per minute.Medication was administered and angiography showed timi flow grade 3.The burr was then upgraded to a 1.75 mm bsc rotalink burr and rotated five times at 160,000 rpm, total 50 seconds, and also successfully passing through the lesion.The patient complained of chest discomfort and angiography showed slow blood flow, timi flow grade 0-1.The physician administered nitroglycerin and verapamil into the coronary artery, which provided some relief.Ivus was used to recheck the results of the rota, which revealed a dissection.A non-bsc microcatheter and bsc samurai guidewire were placed, and the first 3.0 x 33mm non-boston scientific (bsc) drug-eluting stent was implanted at 10 atm in the mid-distal rca.Medication was administered and angiography still showed timi flow grade 0-1.Ivus showed no signs of dissection in the distal segment.A 3.0 x 15mm non-bsc non-compliant balloon was then introduced and inflated at 12-22 atm to post-dilate the stent.More medication was administered into the coronary artery.Angiography now sowed timi flow grade 2-3.A 3.5 x 33mm non-bsc drug eluting stent was implanted at 10-12 atm, in the mid-proximal rca with good apposition to the previous stent and precise positioning at the rca ostium.A 3.5 x 15mm non-bsc non-compliant balloon was then inflated at 12-22 atm to post-dilate the stent.The patient complained of chest discomfort and angiography again showed timi flow grade 0-1.Additional medication was administered into the coronary artery which resulted in angiography revealing timi flow grade 1-2.The ecg then showed atrial fibrillation and the patient's blood pressure dropped to 90/60mmhg.More medication was administered intracoronary and continued intravenously.Ventricular fibrillation then occurred, and the patient immediately lost consciousness.Resuscitation measures were taken, including electrical defibrillation, chest compressions and endotracheal intubation.Ventricular fibrillation persisted and all resuscitation efforts were continued, ultimately leading to ventricular escape rhythm.Additional right femoral vein access was gained, and a temporary pacing electrode was introduced, pacing set at 100 beats per minute.The patient was connected to a ventilator and resuscitation efforts continued, however, the patient was declared clinically dead after 40 minutes.As per the physician's opinion, "both the ivus and rota were performed according to standard procedures during the procedure, with stable device operation and no abnormality occurred of the consumables.The use of consumables was in accordance with the standards, and there were no complications related to the consumables.Dissection and slow blood flow are common complications of the rota procedure, and the physician also handled them in the correct manner.Preliminary exclusion of patient death due to equipment or consumable issues." no further details were reported in relation to this event.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Media review: procedural media was provided and was reviewed by a member of boston scientific medical safety.Media review was unable to confirm a dissection.Based on the available images and information, it is not possible to fully determine the cascade of events that led to the patient death and there does not appear to be any device related issues.
Event or Problem Description
It was reported that dissection, slow blood flow and arrythmia occurred and the patient expired.The patient was elderly, with triple-vessel coronary artery disease and was considered high-risk with complex lesions.Coronary artery bypass grafting (cabg) surgery was recommended half a month prior.The patient was admitted to the hospital on (b)(6)2025 requesting percutaneous coronary intervention (pci).The doctor, physician, and the hospital medical affairs department had thorough communication and informed the family of the high risks involved.Access was obtained via the right radial artery.Angiography and opticross intravascular ultrasound (ivus) both revealed 99% stenosis, severely calcified lesions in the mid-proximal segment in the right coronary artery (rca).Additionally, diffuse calcified lesions with 80-90% stenosis were observed in the mid-proximal segment of the left anterior descending artery (lad) and diffuse calcified lesions with 99% stenosis in the diagonal branch.Diffuse calcified lesions with 80-90% stenosis were also noted in the mid-proximal segment of the left circumflex artery (lcx).A 2.0 x 20mm maverick balloon was inflated at 12 atmospheres (atm) to dilate the rca lesion, showing a significant waist sign on the balloon.Ivus revealed diffuse 360-degree circumferential calcification in the rca, with a minimum lumen diameter of 1.3mm.Rotational atherectomy (rota) was then performed in the rca plaque using a boston scientific (bsc) 1.5 mm rotaburr.The burr was rotated four times at 160,000 revolutions per minute (rpm), total 48 seconds, and successfully passed through the lesion.During rotablation, the patient's electrocardiogram (ecg) showed a heart rate drop to 50 beats per minute.Medication was administered and angiography showed timi flow grade 3.The burr was then upgraded to a 1.75 mm bsc rotalink burr and rotated five times at 160,000 rpm, total 50 seconds, and also successfully passing through the lesion.The patient complained of chest discomfort and angiography showed slow blood flow, timi flow grade 0-1.The physician administered nitroglycerin and verapamil into the coronary artery, which provided some relief.Ivus was used to recheck the results of the rota, which revealed a dissection.A non-bsc microcatheter and bsc samurai guidewire were placed, and the first 3.0 x 33mm non-boston scientific (bsc) drug-eluting stent was implanted at 10 atm in the mid-distal rca.Medication was administered and angiography still showed timi flow grade 0-1.Ivus showed no signs of dissection in the distal segment.A 3.0 x 15mm non-bsc non-compliant balloon was then introduced and inflated at 12-22 atm to post-dilate the stent.More medication was administered into the coronary artery.Angiography now sowed timi flow grade 2-3.A 3.5 x 33mm non-bsc drug eluting stent was implanted at 10-12 atm, in the mid-proximal rca with good apposition to the previous stent and precise positioning at the rca ostium.A 3.5 x 15mm non-bsc non-compliant balloon was then inflated at 12-22 atm to post-dilate the stent.The patient complained of chest discomfort and angiography again showed timi flow grade 0-1.Additional medication was administered into the coronary artery which resulted in angiography revealing timi flow grade 1-2.The ecg then showed atrial fibrillation and the patient's blood pressure dropped to 90/60mmhg.More medication was administered intracoronary and continued intravenously.Ventricular fibrillation then occurred, and the patient immediately lost consciousness.Resuscitation measures were taken, including electrical defibrillation, chest compressions and endotracheal intubation.Ventricular fibrillation persisted and all resuscitation efforts were continued, ultimately leading to ventricular escape rhythm.Additional right femoral vein access was gained, and a temporary pacing electrode was introduced, pacing set at 100 beats per minute.The patient was connected to a ventilator and resuscitation efforts continued, however, the patient was declared clinically dead after 40 minutes.As per the physician's opinion, "both the ivus and rota were performed according to standard procedures during the procedure, with stable device operation and no abnormality occurred of the consumables.The use of consumables was in accordance with the standards, and there were no complications related to the consumables.Dissection and slow blood flow are common complications of the rota procedure, and the physician also handled them in the correct manner.Preliminary exclusion of patient death due to equipment or consumable issues." no further details were reported in relation to this event.It was further reported that it could not be completely confirmed whether a dissection occurred after the 1.75 mm rotational atherectomy was used.The procedure record provided by the physician did not indicate that a dissection occurred.
Additional Manufacturer Narrative
H6 impact codes: corrected.E1 - initial reporter facility name: (b)(6).Media review: procedural media was provided and was reviewed by a member of boston scientific medical safety.Media review was unable to confirm a dissection.Based on the available images and information, it is not possible to fully determine the cascade of events that led to the patient death and there does not appear to be any device related issues.
Event or Problem Description
It was reported that dissection, slow blood flow and arrythmia occurred and the patient expired.The patient was elderly, with triple-vessel coronary artery disease and was considered high-risk with complex lesions.Coronary artery bypass grafting (cabg) surgery was recommended half a month prior.The patient was admitted to the hospital on (b)(6) 2025 requesting percutaneous coronary intervention (pci).The doctor, physician, and the hospital medical affairs department had thorough communication and informed the family of the high risks involved.Access was obtained via the right radial artery.Angiography and opticross intravascular ultrasound (ivus) both revealed 99% stenosis, severely calcified lesions in the mid-proximal segment in the right coronary artery (rca).Additionally, diffuse calcified lesions with 80-90% stenosis were observed in the mid-proximal segment of the left anterior descending artery (lad) and diffuse calcified lesions with 99% stenosis in the diagonal branch.Diffuse calcified lesions with 80-90% stenosis were also noted in the mid-proximal segment of the left circumflex artery (lcx).A 2.0 x 20mm maverick balloon was inflated at 12 atmospheres (atm) to dilate the rca lesion, showing a significant waist sign on the balloon.Ivus revealed diffuse 360-degree circumferential calcification in the rca, with a minimum lumen diameter of 1.3mm.Rotational atherectomy (rota) was then performed in the rca plaque using a boston scientific (bsc) 1.5 mm rotaburr.The burr was rotated four times at 160,000 revolutions per minute (rpm), total 48 seconds, and successfully passed through the lesion.During rotablation, the patient's electrocardiogram (ecg) showed a heart rate drop to 50 beats per minute.Medication was administered and angiography showed timi flow grade 3.The burr was then upgraded to a 1.75 mm bsc rotalink burr and rotated five times at 160,000 rpm, total 50 seconds, and also successfully passing through the lesion.The patient complained of chest discomfort and angiography showed slow blood flow, timi flow grade 0-1.The physician administered nitroglycerin and verapamil into the coronary artery, which provided some relief.Ivus was used to recheck the results of the rota, which revealed a dissection.A non-bsc microcatheter and bsc samurai guidewire were placed, and the first 3.0 x 33mm non-boston scientific (bsc) drug-eluting stent was implanted at 10 atm in the mid-distal rca.Medication was administered and angiography still showed timi flow grade 0-1.Ivus showed no signs of dissection in the distal segment.A 3.0 x 15mm non-bsc non-compliant balloon was then introduced and inflated at 12-22 atm to post-dilate the stent.More medication was administered into the coronary artery.Angiography now sowed timi flow grade 2-3.A 3.5 x 33mm non-bsc drug eluting stent was implanted at 10-12 atm, in the mid-proximal rca with good apposition to the previous stent and precise positioning at the rca ostium.A 3.5 x 15mm non-bsc non-compliant balloon was then inflated at 12-22 atm to post-dilate the stent.The patient complained of chest discomfort and angiography again showed timi flow grade 0-1.Additional medication was administered into the coronary artery which resulted in angiography revealing timi flow grade 1-2.The ecg then showed atrial fibrillation and the patient's blood pressure dropped to 90/60mmhg.More medication was administered intracoronary and continued intravenously.Ventricular fibrillation then occurred, and the patient immediately lost consciousness.Resuscitation measures were taken, including electrical defibrillation, chest compressions and endotracheal intubation.Ventricular fibrillation persisted and all resuscitation efforts were continued, ultimately leading to ventricular escape rhythm.Additional right femoral vein access was gained, and a temporary pacing electrode was introduced, pacing set at 100 beats per minute.The patient was connected to a ventilator and resuscitation efforts continued, however, the patient was declared clinically dead after 40 minutes.As per the physician's opinion, "both the ivus and rota were performed according to standard procedures during the procedure, with stable device operation and no abnormality occurred of the consumables.The use of consumables was in accordance with the standards, and there were no complications related to the consumables.Dissection and slow blood flow are common complications of the rota procedure, and the physician also handled them in the correct manner.Preliminary exclusion of patient death due to equipment or consumable issues." no further details were reported in relation to this event.It was further reported that it could not be completely confirmed whether a dissection occurred after the 1.75 mm rotational atherectomy was used.The procedure record provided by the physician did not indicate that a dissection occurred.

• 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 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: 21939691
• Report Number: 2124215-2025-23955
• Device Sequence Number: 18315670
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: (01)08714729185840(17)270102(10)35542314
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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
• Device Lot Number: 0035542314
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 10/14/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/13/2025; 10/15/2025
• Date Device Manufactured: 01/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 52 KG