MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number 2077-01

Device Problem Entrapment of Device (1212)

Patient Problems Ventricular Fibrillation (2130); Embolism/Embolus (4438)

Event Date 01/19/2022

Event Type  Death  

Event Description

It was reported that the burr became stuck on the rotawire, a ventricular fibrillation and death occurred.The target lesion was located in the severely tortuous and severely calcified proximal left anterior descending artery (lad).A 1.75mm rotapro and rotawire drive were selected for use in the percutaneous coronary intervention (pci) procedure.Ablation was performed with rotapro burr.During removal, the burr was stuck in the rotawire inside the patient.The rotapro and the rotawire were removed together as one unit from the patient.The patient condition suddenly changed and became ventricular fibrillation.After cardiac massage, the patient stabilized, and a 3.00 x 48mm synergy xd drug-eluting stent was implanted to complete the procedure.After the patient transferred to hcu (high care unit), the patient condition suddenly changed and developed ventricular fibrillation again.An intra-aortic balloon pumping (iabp) and percutaneous cardiopulmonary support (pcps) was inserted, and the patient was monitored.However, it was confirmed that the patient died on (b)(6) 2022.Autopsy result showed that the patient died of stent thrombosis.In the physician opinion, the rotapro treatment might have caused a distal embolus.

Event Description

It was reported that the burr became stuck on the rotawire, a ventricular fibrillation and death occurred.The target lesion was located in the severely tortuous and severely calcified proximal left anterior descending artery (lad).A 1.75mm rotapro and rotawire drive were selected for use in the percutaneous coronary intervention (pci) procedure.Ablation was performed with rotapro burr.During removal, the burr was stuck in the rotawire inside the patient.The rotapro and the rotawire were removed together as one unit from the patient.The patient condition suddenly changed and became ventricular fibrillation.After cardiac massage, the patient stabilized, and a 3.00 x 48mm synergy xd drug-eluting stent was implanted to complete the procedure.After the patient transferred to hcu (high care unit), the patient condition suddenly changed and developed ventricular fibrillation again.An intra-aortic balloon pumping (iabp) and percutaneous cardiopulmonary support (pcps) was inserted, and the patient was monitored.However, it was confirmed that the patient died on (b)(6) 2022.Autopsy result showed that the patient died of stent thrombosis.In the physician opinion, the rotapro treatment might have caused a distal embolus.

• Brand Name: ROTAWIRE DRIVE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13480753
• MDR Text Key: 285235987
• Report Number: 2134265-2022-01269
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2022

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: 03/29/2023
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0027053654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Male