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

Model Number	H749236310030
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination of the device revealed that the handshake connection was separated and bent.The coil was kinked at the handshake connection.There was blood present within the sheath.The returned wire was frozen within the device due to damages present to the rotalink device and the rotawire.There were numerous severe kinks to the wire preventing removal.
Event or Problem Description
It was reported that crossing difficulties or failure occurred.The 98% target lesion was located in the severely tortuous and severely calcified artery.A 1.50mm rotablator rotalink plus was selected for complex percutaneous transluminal coronary angioplasty (ptca).During procedure, it was noted that the device failed to cross the lesion.The procedure was completed.There were no patient complications.However, based on the additional information from the related complaint investigation result, it was confirmed that the burr was stuck.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination of the device revealed that the handshake connection was separated and bent.The coil was kinked at the handshake connection.There was blood present within the sheath.The returned wire was frozen within the device due to damages present to the rotalink device and the rotawire.There were numerous severe kinks to the wire preventing removal.
Event or Problem Description
Reportable based on the additional information from the related complaint investigation result on 05sep2025.It was reported that crossing difficulties or failure occurred.The 98% target lesion was located in the severely tortuous and severely calcified artery.A 1.50mm rotablator rotalink plus was selected for complex percutaneous transluminal coronary angioplasty (ptca).During procedure, it was noted that the device failed to cross the lesion.The procedure was completed.There were no patient complications.However, based on the additional information from the related complaint investigation result, it was confirmed that the burr was stuck.

• 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: 23201390
• Report Number: 2124215-2025-69264
• Device Sequence Number: 10062076
• 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,Followup
• Report Date (Section B): 11/13/2025

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: 08/04/2026
• Device Model Number: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0034763614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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