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

Model Number 3256

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled due to the device issue.A rotapro console 230v was selected for use during a procedure.During preparation for the procedure, it was noted that the console was releasing air through the front connection as well as through the back of the console.Because of this issue, the procedure was not able to be completed.Patient sedation status at the time of the procedure cancellation is unknown, however there were no patient complications reported due to this event.

Manufacturer Narrative

The returned product consisted of the rotapro console.Visual inspection showed no irregularities or damages.Upon connecting the console and turning up the air pressure, an air leak was detected.When the console was opened to investigate the air leak the pressure release valve on the pneumatic kit was found to be stuck in a semi open state.When the pressure release valve was manipulated by hand a piece of fm that had been causing the pneumatic kit to stick in the open state fell out.

Event Description

It was reported that the procedure was cancelled due to the device issue.A rotapro console 230v was selected for use during a procedure.During preparation for the procedure, it was noted that the console was releasing air through the front connection as well as through the back of the console.Because of this issue, the procedure was not able to be completed.Patient sedation status at the time of the procedure cancellation is unknown, however there were no patient complications reported due to this event.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17961011
• MDR Text Key: 325983969
• Report Number: 2124215-2023-57694
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P900056/S166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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 Model Number: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP006023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1