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

Model Number	2077-02
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire separation occurred with a retained fragment and procedure was cancelled.\ \ the 30 mm long and 90% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery with a vessel diameter of 3.00- 3.40 mm.A rotawire and 1.75mm rotapro was selected for use.During removal, resistance was encountered and an unusual sound was heard.The guidewire detached 5 cm from the tip due to contact with the burr.Per the physician.The wire may have been kinked.Attempts to retrieve the device fragment with a non-boston scientific balloons, guide extension catheter and guidewire were unsuccessful.The detached device segment remained inside the patient and the procedure was cancelled as there were no additional devices available.
Event or Problem Description
It was reported that guidewire separation occurred with a retained fragment and procedure was cancelled.The 30 mm long and 90% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery with a vessel diameter of 3.00- 3.40 mm.A rotawire and 1.75mm rotapro was selected for use.During removal, resistance was encountered and an unusual sound was heard.The guidewire detached 5 cm from the tip due to contact with the burr.Per the physician.The wire may have been kinked.Attempts to retrieve the device fragment with a non-boston scientific balloons, guide extension catheter and guidewire were unsuccessful.The detached device segment remained inside the patient and the procedure was cancelled as there were no additional devices available.
Additional Manufacturer Narrative
Investigation results:\ device analysis findings:\ the device was not returned for analysis; therefore, a technical analysis could not be performed.\ \ 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 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 issue could be related to factors that can occur with the interaction between the rotapro and rotawire, as well as operational factors such as handling/technique at the moment to manipulate both devices, causing the reported events.Regarding the patient and impact codes of unretrieved device fragments (udf), additional device required and cancelled/rescheduled - post sedation/sedation unknown.The assigned cause code is adverse event related to procedure, since due to the detachment of the distal tip of the rotawire, additional devices were required in order to remove the unretrieved portion of it, without any success, consequently leading to procedure cancellation due to the lack of available devices, with can be attributable to factors that can occur during procedure with the use of the device.Furthermore, according to medical review, the clinical event is anticipated in nature and severity.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25398411
• Report Number: 2124215-2026-29933
• Device Sequence Number: 18821181
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)280205(10)38526748
• 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): 06/30/2026

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: 0038526748
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 02/05/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON - 1.5 RYUREI; BALLOON - 2.0 RYUREI; GUIDE EXTENSION - GUIDEPLUS; GUIDEWIRE - 7FR SION BLUE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male