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

Model Number	2077-02
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device was difficult to remove.The 90% stenosed, 15 x 3.00mm target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery (lad).A rotawire drive was selected for use with a rotapro and ablation was performed without any issues.The rotawire became stuck in the peripheral lad so a microcatheter was advanced, and an attempt was made to replace the wire with an 0.014 wire.Due to strong resistance and concerns about wire separation, actions were stopped.The advancement of the microcatheter was also insufficient, so to soften the calcification, intravascular lithotripsy (ivl) was performed on the proximal lad.Afterward, the catheter was able to cross more easily and the rotawire was successfully retrieved.There were no patient complications.
Additional Manufacturer Narrative
Investigation results: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device revealed that the distal tip was found bent.No other issues were identified during the product analysis.Device history review (dhr): it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Media review: the device was returned for analysis.During the product analysis, it was found the distal tip bent, which confirms the reported guidewire, difficult to remove.Most probable root cause and conclusion: an investigation conclusion code of adverse event related to patient condition have been assigned following a review of the reported event details, available information, and product record review.During product analysis it was observed the distal tip bent, it is most likely the presence of anatomical factors presented a constriction over the wire and increase the friction when the device was advancing through the lesion reducing the mobility and generating the reported issue.Batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.Relevance evaluation: unable to determine.
Event or Problem Description
It was reported that device was difficult to remove.The 90% stenosed, 15 x 3.00mm target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery (lad).A rotawire drive was selected for use with a rotapro and ablation was performed without any issues.The rotawire became stuck in the peripheral lad so a microcatheter was advanced, and an attempt was made to replace the wire with an 0.014 wire.Due to strong resistance and concerns about wire separation, actions were stopped.The advancement of the microcatheter was also insufficient, so to soften the calcification, intravascular lithotripsy (ivl) was performed on the proximal lad.Afterward, the catheter was able to cross more easily and the rotawire was successfully retrieved.There were no patient complications.

• 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: 24086253
• Report Number: 2124215-2026-02999
• Device Sequence Number: 9684025
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)270703(10)36894286
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0036894286
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown