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

Model Number	H749236310020
Medical Device Problem Codes	Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter first name: (b)(6).
Event or Problem Description
It was reported that rotation speed was unstable.A 1.25mm rotablator rotalink plus was selected for use.During the procedure, a loud noise of air leaking was heard during the pressure test and the advancer was difficult to handle.When the burr rotation was adjusted, the rotation frequency was compromised.The procedure was completed with another of the same device.No complications were reported.
Event or Problem Description
It was reported that rotation speed was unstable.A 1.25mm rotablator rotalink plus was selected for use.During the procedure, a loud noise of air leaking was heard during the pressure test and the advancer was difficult to handle.When the burr rotation was adjusted, the rotation frequency was compromised.The procedure was completed with another of the same device.No complications were reported.
Additional Manufacturer Narrative
E1: initial reporter first name: (b)(6).G2 report source: corrected.The device was returned for analysis.A visual examination of the device did not identify any damages or defects.In order to determine the reason for the device stall, the advancer was dismantled and the components inside the advancer were inspected.It was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.The rotablator system was connected to the rotablator control console system.When the foot pedal was pushed, the device did not get any speed, and a stall error was displayed on the console.The sound of air escaping the device could be heard.

• 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: 21102837
• Report Number: 2124215-2024-82124
• Device Sequence Number: 18418402
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 10/21/2025
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0032900687
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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