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); Perforation of Vessels (2135)

Event Date 10/22/2020

Event Type  Death  

Event Description

It was reported that patient death occurred.A 1.75mm rotapro and rotawire were used in an atherectomy procedure in the left anterior descending artery (lad) lesion.Ablation was completed in the lesion and more proximal without issue.Rotation was performed at 155000 rotations per minute (rpm) and a total of three passes for durations of 20, 22, and 16 seconds were made.It looked good so the procedure was continued with ballooning and stenting.There was issue with the non-boston scientific stent crossing.Perforation occurred in the lad.The patient became hypotensive, unresponsive, 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10813569
• MDR Text Key: 215463742
• Report Number: 2134265-2020-15565
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

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: 09/29/2021
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0024516224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR