MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RotaLink? Plus; catheter, coronary, atherectomy

Model Number	H749236310030
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	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was stuck requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 1.50mm rotablator rotalink plus was selected for use.During the procedure, the device was operated at a set rotational speed of 180k rpm, with a maximum observed speed of 190k rpm.Significant resistance between the burr and guidewire was experienced.The burr became stuck within the lesion, and the deceleration indicator appeared.Due to the burr entrapment, the catheter and guidewire were removed together as one unit, with balloon dilatation utilized to facilitate device retrieval.The procedure was completed with another of the same device.There were no further patient complications, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).

• 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; business and technology park,; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50326183
• Report Number: 2124215-2026-44592
• Device Sequence Number: 21271726
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)270423(10)36593545
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0036593545
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown