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

Model Number	H749236310020
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.Inspection of the device found that at 41cm from the distal tip of the sheath, the sheath was torn.Blood was present at the tear in the sheath.A microscopic inspection of the device found no damage or irregularity.Media inspection depicted a sheath leak near the distal end of the sheath confirming the reported events as the leak near the tip would indicate damage to the sheath.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 19sep2025.It was reported that the wall of the catheter was damaged.The target lesion was located in the calcified middle segment of left anterior descending artery.A 1.25 mm rotablator plus was selected for use.Prior to procedure, the wall of the catheter was damaged.The procedure was completed with another of the same device.There were no complications, and patient was stable post procedure.However, device analysis revealed that the sheath was torn at 41cm from the distal tip of the sheath with blood present.

• 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: 23301393
• Report Number: 2124215-2025-71987
• Device Sequence Number: 4890291
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)260629(10)34523604
• 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
• Report Date (Section B): 10/15/2025

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: 06/29/2026
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0034523604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG