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

Model Number 39467-125

Device Problems Detachment of Device or Device Component (2907); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

It was reported that the burr broke.A 1.25mm rotapro was selected for use in an atherectomy procedure.During the procedure, rotation speed was unstable in dynaglide mode.There seemed to be a break in the burr.The procedure was completed with another rotapro.No patient complications were reported.

Event Description

It was reported that the burr broke.A 1.25mm rotapro was selected for use in an atherectomy procedure.During the procedure, rotation speed was unstable in dynaglide mode.There seemed to be a break in the burr.The procedure was completed with another rotapro.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the burr presented no breaks or damage.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to rotate.Additional functional testing was performed by connecting the rotapro advancer to the rotapro control console system.When the knob switch was pushed, the advancer did not run.There was no speed and a stall error was displayed on the console.When placed in dynaglide mode, again there was no speed and a stall error was displayed on the console.The advancer was dismantled and the components inside the advancer were inspected.No damage or irregularities were identified.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11229260
• MDR Text Key: 228696579
• Report Number: 2134265-2021-00744
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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: 06/08/2022
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0025570948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/19/2021
• Patient Sequence Number: 1