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

Model Number	2077-01
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire detached.The patient presented with a chronic total occlusion in the right coronary artery.A rotawire drive was selected for use.During procedure, after the guidewire was successfully advanced, the device could not be passed through.Following standard protocol, the rotational atherectomy system was deployed without a guidewire, and treatment was performed using a 1.25 mm burr.The rotawire was found to have fractured.A post-procedure measurement of the involved length and ct scan indicated that the wire had fractured within the coronary artery.Physician recommended a surgical bypass followed by repeat percutaneous intervention, but the patient refused and requested conservative treatment.The patient currently has no symptoms and has been discharged.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6) with all the available information, boston scientific concludes: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Investigation conclusion: this investigation has been assigned the conclusion code of adverse event related to procedure following a review of the reported event details, available information, and product record review.It is likely that the issues could be related to an excessive force applied to the device during procedure, as well as operational factors such as handling/technique, causing the reported events, furthermore, batch record review concluded that no manufacturing deviations were identified during the manufacturing process.Regarding the patient and impact codes unretrieved device fragments (udf) and imaging required according to the event description, the guidewire difficult to track over wire and guidewire detachment of device or device component may have been caused by a possible device malfunction that resulted in the reported issues.The data reasonably suggests that the clinical event is anticipated in nature and severity as per the instructions for use.

• 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: 50568430
• Report Number: 2124215-2026-46367
• Device Sequence Number: 21356746
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262(17)270428(10)36389908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0036389908
• 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: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 04/28/2025
• 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: Other
• Patient Sex: Unknown