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

Model Number	H749236310020
Medical Device Problem Codes	Failure to Advance (2524); Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A 1.25mm rotablator plus was selected for use.During test outside the patient, the rotation speed did not go up, and it had abnormal sound.The procedure was not completed due to this event.
Additional Manufacturer Narrative
E1-initial reporter facility name: (b)(6) hospital.E1-initial reporter address 1: (b)(6).E1-initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, the conclusion code assigned to this investigation was cause not established.There are numerous potential reasons for the device to make abnormal noises with rotational issues, such as coil damages, handshake connection damages, saline infusion issues, ultem melting, etc, but a potential cause among these cannot be established using the information available.Therefore, the reported events could not be confirmed and a potential root cause was not able to be determined.E1- (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.A 1.25mm rotablator plus was selected for use.During test outside the patient, the rotation speed did not go up, and it had abnormal sound.The procedure was not completed due to this event.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).H6-device codes: corrected.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, the conclusion code assigned to this investigation was cause not established.There are numerous potential reasons for the device to make abnormal noises with rotational issues, such as coil damages, handshake connection damages, saline infusion issues, ultem melting, etc, but a potential cause among these cannot be established using the information available.Therefore, the reported events could not be confirmed and a potential root cause was not able to be determined.E1-initial reporter facility name: (b)(6).E1-initial reporter address 1: (b)(6).E1-initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.A 1.25mm rotablator plus was selected for use.During test outside the patient, the rotation speed did not go up, and it had abnormal sound.The procedure was not completed due to this event.It was further reported that the device was unable to cross the lesion, and procedure was cancelled.The patient was sedated with local anesthesia.

• 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: 24473960
• Report Number: 2124215-2026-11118
• Device Sequence Number: 13293454
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)270817(10)37462449
• 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): 04/29/2026

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 Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0037462449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 04/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/29/2026
• Date Device Manufactured: 09/16/2025
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG