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

Model Number 3520

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Ventricular Fibrillation (2130); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 03/04/2021

Event Type  Death  

Event Description

It was reported that the tip of the guidewire detached, and patient death occurred.A 330cm rotawire and wireclip torquer was selected for use in an atherectomy procedure in the ostial right coronary artery (rca) to treat angina pectoris.A bypass was used to retrograde the seg.1 of the rca.After ablation was successfully performed, the rotawire was withdrawn.Upon removal, it was discovered that the 2.2cm radiopaque tip of the guidewire remained in the proximal portion of the vessel.A stent was implanted to push the device fragment into the vessel wall.Thrombus formation occurred, and the patient went into ventricular fibrillation.Cardiac massage was performed, and the patient was ventilated and transferred to the intensive care unit.The patient died on (b)(6) 2021.

Event Description

It was reported that the tip of the guidewire detached, and patient death occurred.A 330cm rotawire and wireclip torquer was selected for use in an atherectomy procedure in the ostial right coronary artery (rca) to treat angina pectoris.A bypass was used to retrograde the seg.1 of the rca.After ablation was successfully performed, the rotawire was withdrawn.Upon removal, it was discovered that the 2.2cm radiopaque tip of the guidewire remained in the proximal portion of the vessel.A stent was implanted to push the device fragment into the vessel wall.Thrombus formation occurred, and the patient went into ventricular fibrillation.Cardiac massage was performed, and the patient was ventilated and transferred to the intensive care unit.The patient died on (b)(6) 2021.It was further reported that thrombus formation started before the stent was implanted.An attempt was made to snare the device fragment.At this time, occlusion of the vessel occurred, and the thrombus formation progressed to the distal portion of the vessel.Under cpr, another complication occurred.The patient experienced a liver partial tear and went to emergency surgery.Using a non-boston scientific heart pump and extracorporeal membrane oxygenation (ecmo), the patient was stabilized.Then the patient experienced acute respiratory distress syndrome (ards) and needed lung ventilation support, but the next of kin did not want that.The physician is of the opinion that the rotawire was related to patient death.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11529498
• MDR Text Key: 241057645
• Report Number: 2134265-2021-03587
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: 08714729185871
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0026212852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention