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

Model Number	H749236310040
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
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 burr became stuck in the lesion.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotablator rotalink plus was selected for use.During the procedure, it was noted that the 1.5 burr got stuck in the lesion.The speed was at 180,000 rpm but the actual speed was only at 120,000 rpm.The procedure was completed with another of the same device.There was no patient injury and the patient was stable after the procedure.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotablator rotalink plus was selected for use.During the procedure, it was noted that the 1.5 burr got stuck in the lesion.The speed was at 180,000 rpm but the actual speed was only at 120,000 rpm.The procedure was completed with another of the same device.There was no patient injury and the patient was stable after the procedure.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A 1.75mm rotablator rotalink plus was selected for use.During the procedure, it was noted that the 1.5 burr got stuck in the lesion.The speed was at 180,000 rpm but the actual speed was only at 120,000 rpm.The procedure was completed with another of the same device.There was no patient injury and the patient was stable after the procedure.
Additional Manufacturer Narrative
H6: device codes: corrected.

• 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: 22365857
• Report Number: 2124215-2025-41079
• Device Sequence Number: 20905096
• Product Code: MCX
• 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,Followup
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2025
• Device Model Number: H749236310040
• Device Catalogue Number: H749236310040
• Device Lot Number: 0031570981
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 08/19/2025; 04/28/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/14/2025; 09/08/2025; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Patient Sex: Unknown