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

Model Number	H749236310020
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The 70-80% stenosed target lesion was located in the moderately tortuous and severely calcified artery.A 1.25mm rotablator rotalink plus and rotawire were selected for use.During the procedure, it was noted that the rota burr was unable to track across the rotawire and got stuck after 2 to 3 rounds of burring.Also, a kink was noted on the device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was received for product analysis.A visual and microscopic inspection of the device found no damage or irregularity.The returned rotawire was used for analysis.During analysis, the rotawire was able to be fully removed and reinserted with no resistance or issues.The rotawire does have minor kink damage which did not cause resistance or impede testing.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The 70-80% stenosed target lesion was located in the moderately tortuous and severely calcified artery.A 1.25mm rotablator rotalink plus and rotawire were selected for use.During the procedure, it was noted that the rota burr was unable to track across the rotawire and got stuck after 2 to 3 rounds of burring.Also, a kink was noted on the device.No patient complications were reported.

• 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: 21041280
• Report Number: 2124215-2024-79786
• Device Sequence Number: 20981129
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Expiration Date: 08/03/2026
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0034757720
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown