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

Model Number	3320
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the sheath was torn and leaked.The 90% stenosed target lesion was located in the middle segment of anterior descending branch.A 1.25mm rotalink burr was selected for coronary artery occlusion procedure.During introduction, the burr catheter entered patient at a low rotation speed.It was noted that the outer skin of the sheath was torn and leaked.The device was removed, and the procedure was successfully completed with another rotalink device.There was no patient complication, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6) hospital.E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device found that the sheath was torn up to approximately 2cm distal from the burr housing strain relief.A photo provided by the customer showed the torn sheath in accordance with findings during analysis.
Event or Problem Description
It was reported that the sheath was torn and leaked.The 90% stenosed target lesion was located in the middle segment of anterior descending branch.A 1.25mm rotalink burr was selected for coronary artery occlusion procedure.During introduction, the burr catheter entered patient at a low rotation speed.It was noted that the outer skin of the sheath was torn and leaked.The device was removed, and the procedure was successfully completed with another rotalink device.There was no patient complication, and the patient was stable post procedure.

• 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 CORK LIMITED; 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: 21978891
• Report Number: 2124215-2025-23886
• Device Sequence Number: 7264975
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)261017(10)35086291
• 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
• Report Date (Section B): 08/12/2025

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: 0035086291
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 55 KG