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	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a detachment occurred resulting in a retained device fragment.The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified circumflex (cx) artery.A 1.25mm rotapro and a rotawire drive were selected for use.During the procedure, the wire was placed across the mid cx vessel but could not be delivered distally.Ablation was performed at 172,000rpm and the burr successfully crossed the calcified portion of the lesion.Dynaglide mode was then activated to retract the burr from the vessel.During removal, the distal tip of the rotawire separated due to burr contact with the distal portion of the wire.The burr and proximal portion of the rotawire were successfully removed from the patient; however, a short distal wire fragment remained within the vessel.Echo was performed and no pericardial effusion was found.A stent was placed over the wire fragment anchoring it to the vessel wall.The procedure was completed and the patient was stable post procedure.
Event or Problem Description
It was reported that a detachment occurred resulting in a retained device fragment.The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified circumflex (cx) artery.A 1.25mm rotapro and a rotawire drive were selected for use.During the procedure, the wire was placed across the mid cx vessel but could not be delivered distally.Ablation was performed at 172,000rpm and the burr successfully crossed the calcified portion of the lesion.Dynaglide mode was then activated to retract the burr from the vessel.During removal, the distal tip of the rotawire separated due to burr contact with the distal portion of the wire.The burr and proximal portion of the rotawire were successfully removed from the patient; however, a short distal wire fragment remained within the vessel.Echo was performed and no pericardial effusion was found.A stent was placed over the wire fragment anchoring it to the vessel wall.The procedure was completed and the patient was stable post procedure.It was further reported that no attempts were performed to retrieve the fragment and that the procedure was completed with the original device.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.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 an investigation conclusion code of adverse event related to patient condition, following a review of the reported event details, available information, and product record review.It is most likely that the presence of reported anatomical factors presented a constriction over the device and increase the friction when the device was advancing through the lesion, reducing the mobility and generating the reported issues.To conclude, regarding the patient and impact code of unretrieved device fragments (udf), additional device required and imaging required according to the event description, the distal tip detachment of device or device component and guidewire difficult to advance may have been caused by a possible device malfunction that resulted in the reported issues.Therefore, adverse event related to patient condition is assigned as the as-analyzed cause code to the reported patient and impact code.

• 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: 50671211
• Report Number: 2124215-2026-47820
• Device Sequence Number: 9540184
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/01/2026

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
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 10/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown