MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE Drive; catheter, coronary, atherectomy

Model Number	2077-01
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13aug2026.It was reported that the wire was kinked.A rotawire drive was selected for use.During unpacking, it was noted that the wire was kinked.A second wire was opened and the same thing occurred.A third wire with a different lot number was able to complete the procedure.There were no patient complications.However, device analysis revealed that the spring tip was detached and did not return for analysis.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Device/media analysis: the device was returned for analysis.During its analysis it was observed that the distal end was kinked.Therefore, the reported issue of guidewire kinked was confirmed.To conclude, during product analysis, it was also found that the spring tip was detached and did not return for analysis.This failure did not contribute to the reported issue.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.Investigation conclusion: this investigation has been assigned an investigation conclusion code of cause not established.This conclusion is supported by the following objective evidence: regarding the reported issue of guidewire kinked and the additional failure.Analysis of the returned device concluded that the distal end was kinked, and the spring tip was detached and did not return for analysis.Based on the information provided and analysis performed, cause not established is selected as the cause code for the reported issue and additional failure since it remains unknown what factors or conditions were present at the field that contributed to the observed damages.Furthermore, batch record review concluded that no manufacturing deviations were identified during the manufacturing process.

• 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 ; +1(612)875-7234
• MDR Report Key: 50674414
• Report Number: 2124215-2026-47908
• Device Sequence Number: 18750857
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0036427613
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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 Sex: Unknown