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

Model Number 3256

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/17/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled/rescheduled post-sedation.A rotapro console was selected for use in an atherectomy procedure.While testing the device outside the body, the rotation speed was inconsistent.There was no evidence of physical damage to the device.The procedure was not completed due to this event.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the console was returned with the electrical connector partially chipped.The rest of the console was in over all good physical condition.The unit passed all incoming functional tests.The damaged electrical damage is cosmetic and did not affect functionality.Functional testing was unable to replicate the fault condition.The rotapro console passed calibration and full functional final testing.

Event Description

It was reported that the procedure was cancelled/rescheduled post-sedation.A rotapro console was selected for use in an atherectomy procedure.While testing the device outside the body, the rotation speed was inconsistent.There was no evidence of physical damage to the device.The procedure was not completed due to this event.No patient complications were 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: 10949331
• MDR Text Key: 219909046
• Report Number: 2134265-2020-16905
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP000895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 03/01/2021
• Patient Sequence Number: 1