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 Ischemia (1942); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 11/29/2021

Event Type  Death  

Event Description

It was reported that patient death occurred.A rotapro was selected for use in the procedure in left anterior descending artery (lad).After ablation completed, the patient's condition suddenly changed during non-boston scientific drug-coated balloon inflation.At that time, the patient blood flow was decreased in the circumflex artery (cx).The percutaneous cardiopulmonary support (pcps) was then inserted, and the procedure completed.The patient died after the procedure.The physician's opinion as to the cause of the death was not related to rotapro device.

Event Description

It was reported that patient death occurred.A rotapro was selected for use in the procedure in left anterior descending artery (lad).After ablation completed, the patient's condition suddenly changed during non-boston scientific drug-coated balloon inflation.At that time, the patient blood flow was decreased in the circumflex artery (cx).The percutaneous cardiopulmonary support (pcps) was then inserted, and the procedure completed.The patient died after the procedure.The physician's opinion as to the cause of the death was not related to rotapro device.It was further reported that a rotapro and 10mm x 3.25mm wolverine coronary cutting balloon were selected for use in the procedure.During the procedure, after ablation was performed in the left main trunk and proximal left anterior descending artery (lad), dilation was performed with wolverine device.The patient died of acute heart failure on (b)(6), 2021.According to the physician, there is no relationship between the decrease in cx flow and rotapro because the site of use is different.The physician thought that the dissection might have occurred when wolverine or dcb was used and reviewed the ivus records, but could not find the cause.

Event Description

It was reported that patient death occurred.A rotapro was selected for use in the procedure in left anterior descending artery (lad).After ablation completed, the patient's condition suddenly changed during non-boston scientific drug-coated balloon inflation.At that time, the patient blood flow was decreased in the circumflex artery (cx).The percutaneous cardiopulmonary support (pcps) was then inserted, and the procedure completed.The patient died after the procedure.The physician's opinion as to the cause of the death was not related to rotapro device.It was further reported that a rotapro and 10mm x 3.25mm wolverine coronary cutting balloon were selected for use in the procedure.During the procedure, after ablation was performed in the left main trunk and proximal left anterior descending artery (lad), dilation was performed with wolverine device.The patient died of acute heart failure on (b)(6) 2021.According to the physician, there is no relationship between the decrease in cx flow and rotapro because the site of use is different.The physician thought that the dissection might have occurred when wolverine or dcb was used and reviewed the ivus records, but could not find the cause.

Manufacturer Narrative

Updated patient codes.

• 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: 12954923
• MDR Text Key: 281874159
• Report Number: 2134265-2021-15436
• 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,Followup,Followup
• Report Date: 01/21/2022

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 Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/08/2021; 01/13/2022
• Supplement Dates FDA Received: 12/14/2021; 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 10MM X 3.25MM WOLVERINECUTTING BALLOON-BSC.; 10MM X 3.25MM WOLVERINECUTTING BALLOON-BSC.
• Patient Outcome(s): Death