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

Model Number	3241
Medical Device Problem Codes	Nonstandard Device (1420); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the coil was detached at the burr end and was stretched for a length of 3cm proximal to the detachment.The burr failed to return for further analysis.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.During device-to-device interaction, when the rotablator plus system was connected to the rotablator console and the foot pedal was pushed, the device stalled and would not run.No other issues were identified during the product analysis.E1-initial reporter address 1: (b)(6).
Event or Problem Description
Reportable based on device analysis completed on 12jan2026.It was reported that device failed to reach optimum speed.A 1.50mm rotablator rotalink plus was selected for use.During procedure, the rota burr was manually taken to the lesion site.Rotablation had begun and the speed was constantly dropping, even after increasing the speed.The set rotational speed was 180k rpm and observed maximum rotational speed was less than 130k rpm.The procedure was completed using another rotalink plus.There were no patient complications.However, device analysis revealed that the detached coil at the burr end.

• 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: 24270087
• Report Number: 2124215-2026-06621
• Device Sequence Number: 9948154
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• 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
• Report Date (Section B): 02/05/2026

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: 05/27/2025
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0031905596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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