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

Model Number 08714729893363

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

Pt was admitted with chest pain / sob, coronary artery calcifications on ct.Pt was to receive an atherectomy with use of rotapro equipment.Cariology team had checked the device with steps to make sure the burr would advance, that the rotaflush was running, that the emergency break was placed on the back of the wire.And verifying that the rpms on the device's power box were at the appropriate level.This was all done outside of the body before placing the device in the pt.No issues were identified at that time.The cardiologist then placed the device where he wanted to use it and began using the device.When the device was used, it only went up to 20-30 rpms and stopped.The monitor box displayed a stall.The cardiologist then tried moving the device back to see if it was too far.He then attempted to use the device again and ran into the same issue with low rpms and stall.As the device was removed, the cardiologist noticed the rotaflush was leaking out about half way back of the drive shaft sheath instead of where it normally flushes out near the burr itself.Another rotapro kit was then tested and used for the duration of the procedure with no incident.No harm to the pt noted during the procedure or subsequent time in the hospital.Pt is expected to be discharged home today.Fda safety report id# (b)(4).

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 9506172
• MDR Text Key: 172591182
• Report Number: MW5091825
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: (01)08714729893363
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 08714729893363
• Device Catalogue Number: H749393001500
• Device Lot Number: 24597703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 89