MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE? DRIVE AND WIRECLIP? TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	H74939463001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687); Pericardial Effusion (3271)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to (b)(6) 2026 since the only given information is the month and year only.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Additionally, 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.
Event or Problem Description
It was reported that a device detachment occurred, resulting in vessel perforation and an unretrieved device fragment that required additional intervention.The patient presented for left and right heart catheterization with coronary angiography and impella support.The target lesion was located in the right coronary artery (rca).A rotawire drive and rotapro were selected for use.During the procedure, the rotawire extra support broke during a rotational atherectomy run, resulting in vessel perforation and a retained wire fragment.A covered stent was placed to stabilize the perforation, followed by two additional stents to secure the retained wire in place and open vessel.The physician then requested intubation, a code was called, and a pericardial drain was placed with reinfusion of blood via sheath.While this was a complex cardiac catheterization case with an inherently increased risk of complications, the physician opted to retain the wire fragment in place due to the patient's critical condition.A subsequent echocardiogram revealed that the pericardial effusion had resolved completely, and the patient was stabilized.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to january 1, 2026 since the only given information is the month and year only.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Additionally, 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.The device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: the device history record review could not be performed due to the lack of a batch number.Investigation conclusion: this investigation has been assigned the conclusion code of adverse event related to procedure following a review of the reported event details, an available information.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 event.To conclude, regarding the patient and impact codes perforation, vessel, pericardial effusion, unretrieved device fragments (udf), additional device required, blood transfusion and intubation.The assigned cause code since as a result of the reported detachment of the rotawire, a perforation occurred, causing that an additional was required to stent the detached portion in place, leading to a pericardial effusion, blood transfusion and intubation for the patient, which can be attributable to factors that can occur during procedure with the use of the device.Additionally, according to medical review, the clinical event is anticipated in nature and severity.
Event or Problem Description
It was reported via voluntary medwatch report #(b)(4) that a device detachment occurred, resulting in vessel perforation and an unretrieved device fragment that required additional intervention.The patient presented with chronic obstructive pulmonary disease (copd), coronary heart disease, and hypertension, and underwent left and right heart catheterization with coronary angiography and impella support.The target lesion was located in the right coronary artery (rca).A rotawire drive and rotapro were selected for use.During the procedure, the rotawire extra support broke during a rotational atherectomy run, resulting in vessel perforation and a retained wire fragment.A covered stent was placed to stabilize the perforation, followed by two additional stents to secure the retained wire in place and open vessel.The physician then requested intubation, a code was called, and a pericardial drain was placed with reinfusion of blood via sheath.While this was a complex cardiac catheterization case with an inherently increased risk of complications, the physician opted to retain the wire fragment in place due to the patient's critical condition.A subsequent echocardiogram revealed that the pericardial effusion had resolved completely, and the patient was stabilized.

• Brand Name: ROTAWIRE? DRIVE AND WIRECLIP? TORQUER
• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24805272
• Report Number: 2124215-2026-18852
• Device Sequence Number: 10682264
• Product Code: MCX
• UDI-Device Identifier: 08714729996231
• UDI-Public: (01)08714729996231
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: H74939463001
• Device Catalogue Number: H74939463001
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/30/2026
• 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: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White