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

Model Number	3320
Medical Device Problem Codes	Nonstandard Device (1420); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Media review: a photo was provided by the customer showing a separated sheath and blood within the sheath.The attached media could not be used to confirm the reported stall but was considered to be associated with attempted use due to the presence of blood within the sheath.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, the most probable cause for this complaint was considered adverse event related to procedure.A review of the device history record [dhr] indicates that the device was manufactured per specification, and there is no indication of sheath damages during unpackaging.As media is present that suggests use of the device within the body and there were no device damages noted during unpackaging, it is considered most likely that the reported events and identified damages to the device within the media were attributable to factors encountered during attempted use of the device.E1-initial reporter phone: (b)(6).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that stall was shown during testing outside the patient.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 1.50mm rotalink burr was selected for use.During preparation, outside the patient, the burr was connected successfully.Stall was shown during testing outside the patient, but it still could not be solved after adjusting the system.The procedure was completed using another of the same device.There were no complications, and patient was stable post procedure.However, device analysis revealed that the sheath was separated.

• 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: 25801001
• Report Number: 2124215-2026-37396
• Device Sequence Number: 14925167
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: (01)08714729185857(17)271020(10)37745140
• 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): 07/13/2026

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: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0037745140
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 10/20/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 76 KG