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

Model Number 39467-150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Ischemia (1942)

Event Date 03/30/2022

Event Type  Death  

Event Description

It was reported that bradycardia, ischemia and death occurred.The 95% stenosed target lesion was located in the mildly to moderately tortuous and moderately to severely calcified left circumflex artery (lcx).A 1.50mm rotapro and rotawire were selected for use in an atherectomy procedure.The rotapro was prepped and platformed at 165000 rpm outside the patient.A 6 fr sheath was advanced in the right femoral artery.The guide and workhorse guidewire were inserted and the wire crossed the lcx lesion.The physician then exchanged the workhorse guidewire for a rotawire.The physician proceeded to advance the rotapro burr slowly over the rotawire to the lcx.Once the burr was near the lesion, the physician released the tension of the rotapro burr and guidewire, and advanced the burr proximal to the lesion.The first run was 5 seconds with no deceleration of speed and the patient was stable.During the second run, while the burr was on, the patient woke, lifted their left leg at the knee, and raised their neck and shoulders.The nurse assisted the patient to lay back down and relax the left leg, and at this same time the physician turned off the burr.This all happened in a 10 second run, and there was no deceleration in speed.The patient heart rate was bradycardic.The physician took an angiogram of the left coronary system.The rotawire and the burr were pulled back from the starting position and removed from the patient.The patient had little to no flow down the left coronary system.The patient heart rate and blood pressure decreased and the physician called a code blue.An advanced cardiovascular life support (acls) algorithm was followed, and the patient received electrical shocks multiple time.During the code, the physician inserted a non-boston scientific ventricular assist device.Eventually, the patient become stable enough to take an angiogram of the left coronary artery and the patient had flow.There was no perforation present.The physician was unsure if there was any evidence of a dissection of the lcx.The patient coded again and passed away.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14120363
• MDR Text Key: 289354788
• Report Number: 2134265-2022-04407
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0027720722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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 Sex: Male