MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number	2077-02
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).
Event or Problem Description
It was reported that the guidewire could not be fixed.The target lesion was located in the left main trunk.A rotalink advancer and a rotawire drive were selected for use.During preparation, outside the patient, it was noted that the rotalink advancer as not compatible with the drive guidewire.There were abnormal noises at low and high speeds.Moreover, when the tail clip was properly clamped, the guidewire could not be fixed, and the guidewire system was withdrawn.The procedure was completed with another of the same device.No patient complications reported and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The body of the guidewire was kinked.The kinks on the body were measured from distal to proximal.Microscopic inspection of the spring tip was observed bent.
Event or Problem Description
It was reported that the guidewire could not be fixed.The target lesion was located in the left main trunk.A rotalink advancer and a rotawire drive were selected for use.During preparation, outside the patient, it was noted that the rotalink advancer as not compatible with the drive guidewire.There were abnormal noises at low and high speeds.Moreover, when the tail clip was properly clamped, the guidewire could not be fixed, when the burr was moving at a low speed, the guide wire had the tendency to move forward or backward, and the guidewire system was withdrawn.The procedure was completed with another of the same device.No patient complications reported and the patient was stable.
Event or Problem Description
It was reported that the guidewire could not be fixed.The target lesion was located in the left main trunk.A rotalink advancer and a rotawire drive were selected for use.During preparation, outside the patient, it was noted that the rotalink advancer as not compatible with the drive guidewire.There were abnormal noises at low and high speeds.Moreover, when the tail clip was properly clamped, the guidewire could not be fixed, when the burr was moving at a low speed, the guide wire had the tendency to move forward or backward, and the guidewire system was withdrawn.The procedure was completed with another of the same device.No patient complications reported and the patient was stable.It was further reported that the guidewire was not locked during advancement and pullback of the burr.The abnormal noises coming from the advancer was further described as "screechy.".
Additional Manufacturer Narrative
B5 describe event or problem : updated.E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The body of the guidewire was kinked.The kinks on the body were measured from distal to proximal.Microscopic inspection of the spring tip was observed bent.

• Brand Name: ROTAWIRE DRIVE
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22956661
• Report Number: 2124215-2025-59338
• Device Sequence Number: 12875095
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)261115(10)35292872
• 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): 12/04/2025

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: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0035292872
• 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: 08/10/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 11/11/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/27/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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 Sex: Male