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

Model Number	H802228240020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/19/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a guidewire fragment retention occurred.A 330cm rotawire was selected for use.During elective angioplasty with a rotablator, there was intravascular retention of a guide fragment.An attempt to remove it was made, but it was unsuccessful.The patient was referred to the icu for continued care.
Event or Problem Description
It was reported that a guidewire fragment retention occurred.A 330cm rotawire was selected for use.During elective angioplasty with a rotablator, there was intravascular retention of a guide fragment.An attempt to remove it was made, but it was unsuccessful.The patient was referred to the icu for continued care.It was further reported that complications arose and the patient subsequently died.
Additional Manufacturer Narrative
B2 date of death was estimated.The date of death is unknown between on (b)(6) 2025.H6 patient codes: insufficient information was used to account for unspecified patient complications arising prior to the patient death.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: ROTAWIRE? 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23769371
• Report Number: 2124215-2025-90154
• Device Sequence Number: 9667531
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871(17)260918(10)34876172
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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 Expiration Date: 09/18/2026
• Device Model Number: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 0034876172
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 09/18/2024
• 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; Death
• Patient Age: 74 YR
• Patient Sex: Unknown