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

Model Number	H80222782001A0
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the guidewire could not be fixed.The target lesion was located in the left main trunk.A rotalink advancer and a rotawire drive were selected for use.During preparation, outside the patient, it was noted that the rotalink advancer as not compatible with the drive guidewire.There were abnormal noises at low and high speeds.Moreover, when the tail clip was properly clamped, the guidewire could not be fixed, and the guidewire system was withdrawn.The procedure was completed with another of the same device.No patient complications reported and the patient was stable.
Event or Problem Description
It was reported that the guidewire could not be fixed.The target lesion was located in the left main trunk.A rotalink advancer and a rotawire drive were selected for use.During preparation, outside the patient, it was noted that the rotalink advancer as not compatible with the drive guidewire.There were abnormal noises at low and high speeds.Moreover, when the tail clip was properly clamped, the guidewire could not be fixed, and the guidewire system was withdrawn.The procedure was completed with another of the same device.No patient complications reported and the patient was stable.It was further reported that the guidewire was not locked during advancement and pullback of the burr.The abnormal noise coming from the advancer was further described as "screechy.".
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Inspection of the device did not identify any damages or defects.Inspection of the device after destructive testing found that the driveshaft (turbine) was corroded, and the collet was found seated within the brake housing and the distal end of the collet was closed.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and remained for further testing.Once testing was completed the wire was removed from the device with no resistance or issues.When the rotablator advancer was connected to the rotablator console and when the foot pedal was pressed, the device stalled and did not run.The sound of air escaping the device could be heard during the stall.Despite device stall during analysis, the brake defeat button was pushed and was able to engage and disengage properly without issue or resistance.However, the test wire had full movement while attempting device rotation and while attempting to test the brake defeat.At no point during testing was the wire locked.In order to determine the reason for the device stall, the advancer was dismantled and the components inside the advancer were inspected.Based on the nature of this finding, an external support form was requested from operations engineering to provide further input.
Event or Problem Description
It was reported that the guidewire could not be fixed.The target lesion was located in the left main trunk.A rotalink advancer and a rotawire drive were selected for use.During preparation, outside the patient, it was noted that the rotalink advancer as not compatible with the drive guidewire.There were abnormal noises at low and high speeds.Moreover, when the tail clip was properly clamped, the guidewire could not be fixed, and the guidewire system was withdrawn.The procedure was completed with another of the same device.No patient complications reported and the patient was stable.It was further reported that during the burr was advanced, the guidewire was not locked no matter advanced or pulled back.

• Brand Name: ROTALINK? ADVANCER
• 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: 22956406
• Report Number: 2124215-2025-59342
• Device Sequence Number: 8453300
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)270407(10)36245275
• 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): 12/25/2025

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 Model Number: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0036245275
• 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: 08/10/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 12/05/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/04/2025; 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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
• Patient Sex: Male