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

Model Number	3320
Medical Device Problem Codes	Decoupling (1145); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a burr detachment occurred.A 1.50mm rotalink burr was selected for use.During the procedure, when the package was opened, it was found that the probe of the burr catheter was not in place.The procedure was completed with a different device.No patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a burr detachment occurred.A 1.50mm rotalink burr was selected for use.During the procedure, when the package was opened, it was found that the probe of the burr catheter was not in place.The procedure was completed with a different device.No patient complications reported.It was further reported that the after the physician opened the product packaging, they found that the connection part of the burr and the advancer including the drive shaft and the handshake connection was missing, and pushing the burr end was also ineffective.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a burr detachment occurred.A 1.50mm rotalink burr was selected for use.During the procedure, when the package was opened, it was found that the probe of the burr catheter was not in place.The procedure was completed with a different device.No patient complications reported.It was further reported that the after the physician opened the product packaging, they found that the connection part of the burr and the advancer including the drive shaft and the handshake connection was missing, and pushing the burr end was also ineffective.

• 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: 22233525
• Report Number: 2124215-2025-37390
• Device Sequence Number: 9042478
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: (01)08714729185857(17)261209(10)35449393
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

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: 0035449393
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 11/25/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/22/2025; 12/19/2025
• Date Device Manufactured: 12/09/2024
• 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: 67 YR
• Patient Sex: Female