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

Model Number 3243

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Output Problem (3005)

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

Event Date 01/08/2021

Event Type  malfunction  

Event Description

It was reported the device was difficult to remove.A 1.25mm rotapro was selected for an atherectomy procedure.During the procedure, stall displayed and the device was difficult to remove.The device was not stuck.When the device was pulled, it released and was able to be removed.The burr tip was observed to be slightly deformed.The procedure was not completed.There were no patient complications reported.

Manufacturer Narrative

H8 usage of device was corrected from reuse to initial use.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 device revealed that the burr was damaged.The damage to the annulus is consistent to the damage due to interaction with the rotawire during the procedure.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to rotate.Then functional testing was performed by connecting the rotapro advancer to the rotapro control console system.When the knob switch (ablation button) was pushed, the advancer was not able to run, so it did not get any speed, and a stall error was displayed on the console.The advancer was dismantled and the components inside the advancer were inspected and it was found that the turbine was corroded.

Event Description

It was reported the device was difficult to remove.A 1.25mm rotapro was selected for an atherectomy procedure.During the procedure, stall displayed and the device was difficult to remove.The device was not stuck.When the device was pulled, it released and was able to be removed.The burr tip was observed to be slightly deformed.The procedure was not completed.There were no patient complications reported.

• 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: 11208004
• MDR Text Key: 227996973
• Report Number: 2134265-2021-00587
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 09/15/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026020419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1