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

Model Number 3256

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

Reportable based on additional information received on 20jan2023.It was reported that the procedure was cancelled.Before a rotapro procedure, it was noted that the rotapro console was leaking gas from the burr connection in front of the device.Also, the valve inside the console seemed broken.The procedure had to be postponed.There were no patient complications reported.

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.Upon visual inspection the rotapro console was in good condition.The device had a total powered on time of 29 hours and had a total procedure time of 31 minutes.The rotapro console failed the cis rotapro manual test.Upon connecting air, a leak was heard coming from the inside of the console and an air leak was noted from the optical connectors in the console.When the rotapro console was opened, the air hose between the rear air inlet connector and the pneumatic kit was found to be disconnected.There was no fitting hose clamp.The investigation confirmed the reported event.

Event Description

It was reported that the procedure was cancelled.Before a rotapro procedure, it was noted that the rotapro console was leaking gas from the burr connection in front of the device.Also, the valve inside the console seemed broken.The procedure had to be postponed.There were no patient complications reported.It was further reported that the patient had not been sedated prior to the cancellation.

• 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): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16372800
• MDR Text Key: 309552895
• Report Number: 2124215-2023-05641
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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: RP003004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1