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

Model Number	3560
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Foreign Body In Patient (2687); Foreign Body Embolism (4439); Insufficient Information (4580); Reduced Blood Flow (4598)
Date of Event	06/25/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that wire detached and the patient died.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified anterior descending artery.A 1.50 mm rotapro and rotawire were selected for use.During the procedure, a deformity/kink was noted in the rotawire near the brake.When the physician attempted to remove the burr while in dynaglide mode, the wire broke and the fragment embolized in the septal vessel.The patient became hemodynamically unstable and no flow was identified in the anterior descending coronary artery.Attempting to open the vessel resulted in several cardiac arrests.The physician was able to successfully open the septal vessel, restoring coronary flow and trapping the wire fragment by deploying two synergy stents, however, the patient was in serious condition.Cardiac resuscitation was attempted several times and an intra-aortic balloon was used to maintain cardiovascular stability.The patient was transferred to the intensive care use (icu) and died the following day.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19667665
• Report Number: 2124215-2024-41050
• Device Sequence Number: 15139819
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 12/15/2024
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0030725898
• 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: 07/01/2024
• Initial Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 12/16/2022
• 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: Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 27 KG