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

Model Number 3243

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

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/24/2021

Event Type  Death  

Event Description

It was reported that the patient expired.A complex percutaneous coronary intervention (pci) procedure was being performed on a heavily calcified proximal to mid right coronary artery (rca).Venous and arterial access was gained and a non-boston scientific pacing lead was inserted into the right ventricle (rv).Rotablation was successfully completed with a 1.75mm rotapro and the pci was completed with placement of a 3.5x48mm and 4.0x12mm synergy drug eluting stents.The temporary pacing wire was removed at the end of the procedure.Post procedure, the patient was stable, the procedure was considered a success and there was no vessel perforation.While the patient was in recovery, the patient's condition deteriorated.They experienced chest pain and a trans-thoracic echo diagnosed a pericardial effusion.There was a perforation in the right ventricle.It was noted that in the physician's opinion the perforation was caused by a non-boston scientific pacing lead.The patient returned to the cardiac catheterization laboratories (ccl) for a pericardiocentesis.The patient later passed away, the cardiologist believed from kidney failure.

• 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: 11858938
• MDR Text Key: 251795480
• Report Number: 2134265-2021-06609
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death