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

Model Number 3256

Device Problems Unstable (1667); Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: approximated to (b)(6) 2020 based on the date boston scientific was made aware of this event.

Event Description

It was reported that the rotation speed was high.A rotapro console was selected for an atherectomy procedure.During platforming outside the patient, rotation was set to 160,000 rpms.Inside the body the speed displayed was 270,000 rpms.The procedure was completed using the same console and rotapro catheter.No patient complications were reported and the patient was stable throughout the procedure and discharged.

Manufacturer Narrative

B3: date of event: approximated to (b)(6) 2020 based on the date boston scientific was made aware of this event.Device evaluated by manufacturer: the console was returned in over all good physical condition.The unit passed all incoming functional tests.Unable to replicate the fault condition.The console has the old version 5.17 firmware installed.The rotapro passed calibration and full functional final testing.The reported erratic speeds complaint was not confirmed.

Event Description

It was reported that the rotation speed was high.A rotapro console was selected for an atherectomy procedure.During platforming outside the patient, rotation was set to 160,000 rpms.Inside the body the speed displayed was 270,000 rpms.The procedure was completed using the same console and rotapro catheter.No patient complications were reported and the patient was stable throughout the procedure and discharged.

• 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: 10684553
• MDR Text Key: 211528826
• Report Number: 2134265-2020-14206
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (y/n): N
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: RP000936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 04/23/2021
• Patient Sequence Number: 1