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

Model Number	H749236310020
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Output Problem (3005)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck in the lesion.The patient underwent a procedure to treat a lesion in the mid-left anterior descending (mid lad) artery, which was tortuous and heavily calcified.A 1.25 mm rotablator rotalink plus was selected for use.After a successful draw test, the physician cleared the proximal side of the lesion.However, during a second attempt, the burr became stuck in the lesion, accompanied by a larger drop in rpm.To ensure patient safety, the device was withdrawn.The attended physician then used small profile balloons, a cutting balloon, and placed stents to finish the procedure.The patient had some pain and discomfort after the procedure and was stabilized with nitroglycerin (ntg).
Event or Problem Description
It was reported that the burr became stuck in the lesion.The patient underwent a procedure to treat a lesion in the mid-left anterior descending (mid lad) artery, which was tortuous and heavily calcified.A 1.25 mm rotablator rotalink plus was selected for use.After a successful draw test, the physician cleared the proximal side of the lesion.However, during a second attempt, the burr became stuck in the lesion, accompanied by a larger drop in rpm.To ensure patient safety, the device was withdrawn.The attended physician then used small profile balloons, a cutting balloon, and placed stents to finish the procedure.The patient had some pain and discomfort after the procedure but felt better after being given nitroglycerin (ntg) and was stable afterward.
Additional Manufacturer Narrative
Correction: h6 device codes.
Additional Manufacturer Narrative
Correction: h6 device codes.Device evaluated by manufacturer: the complaint device was received for product analysis.A visual inspection of the device found that majority of the coil was kinked and stretched at the burr.The annulus of the burr was damaged consistent with damage caused from device (wire) interaction during rotation.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.When the rotablator system was connected to the rotablator console and the foot pedal was pressed, the device stalled and did not run.In order to determine the reason for the device stall, the advancer was dismantled and the components inside the advancer were inspected.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The patient underwent a procedure to treat a lesion in the mid-left anterior descending (mid lad) artery, which was tortuous and heavily calcified.A 1.25 mm rotablator rotalink plus was selected for use.After a successful draw test, the physician cleared the proximal side of the lesion.However, during a second attempt, the burr became stuck in the lesion, accompanied by a larger drop in rpm.To ensure patient safety, the device was withdrawn.The attended physician then used small profile balloons, a cutting balloon, and placed stents to finish the procedure.The patient had some pain and discomfort after the procedure but felt better after being given nitroglycerin (ntg) and was stable afterward.

• Brand Name: ROTALINK? PLUS
• 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: 22049214
• Report Number: 2124215-2025-27555
• Device Sequence Number: 9061471
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)260730(10)34746311
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2026
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0034746311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 11/13/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/23/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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 Sex: Unknown