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

Model Number	3320
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: no.(b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a burr tip detachment occurred.The target lesion was located in the anterior descending artery.A1.75mm rotalink burr was selected for use.During preparation, it was noted that the tip of the device was fractured.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b))6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that burr tip detachment occurred.The target lesion was located in the anterior descending artery.A1.75mm rotalink burr was selected for use.During preparation, it was noted that the tip of the device was fractured.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that 75% stenosed target lesion was located in the severely tortuous.The detached burr tip was completely removed from the patient.
Event or Problem Description
It was reported that burr tip detachment occurred.The target lesion was located in the anterior descending artery.A1.75mm rotalink burr was selected for use.During preparation, it was noted that the tip of the device was fractured.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that 75% stenosed target lesion was located in the severely tortuous.The detached burr tip was completely removed from the patient.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by manufacturer: the complaint device was received for product analysis.A visual inspection of the device identified that at 17.5cm proximal from the tip of the sheath, the sheath was detached (torn).The majority of the coil from the handshake connection to the burr was found to be stretched.No other issues were identified during the product analysis.

• Brand Name: ROTALINK BURR
• 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: 22994629
• Report Number: 2124215-2025-60985
• Device Sequence Number: 8806556
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: (01)08714729185840(17)270106(10)35564134
• 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): 11/22/2025

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: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0035564134
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/29/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/29/2025; 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG