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 Death (1802); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Ventricular Fibrillation (2130)

Event Date 11/11/2020

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that patient death occurred.A 1.75mm rotapro was selected for use in the severely calcified proximal and mid left anterior descending artery (lad).There were multiple plaque locations and the length of the lesion was long at 40mm.During the procedure in the proximal lad, st elevation and a decrease of blood pressure was observed.Drugs were administered.The rotapro was passed while blood flow was slowly flowing.Upon use within the mid lad, it went down to 10,000 and ventricular fibrillation occurred.There were no rotapro device issues during the procedure.An intra-aortic balloon pump (iabp) was introduced.However, blood pressure did not recover and the patient died.The cause of death was circulation insufficiency.It was suspected that the 1.75mm size use in the mid lad or continuation of treatment within the mid lad may have contributed to the event.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10876014
• MDR Text Key: 217365706
• Report Number: 2134265-2020-16170
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

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: 08/11/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025842926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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