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

Model Number H749394671250

Device Problems Decrease in Pressure (1490); Gas/Air Leak (2946); Noise, Audible (3273)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

Mid 80¿s male with history of paroxysmal chronic hypoxic respiratory failure, atrial fibrillation, shortness of breath and recent nstemi.Procedure: percutaneous coronary intervention (pci), right coronary artery (rca) rotablation.During the procedure, the rotapro stalled and lost pressure.There was a whistling sound and it appeared to have a leak in the tubing delivering nitrous oxide(just before handle) insertion site.Blood appeared in the handle and gas turned off.Device removed without known harm to the patient.Another rotapro was used without problems.Leak was from clear tubing in picture, close to the handle.Please see blood in tubing and in chamber of handle.

• Brand Name: ROTAPRO¿
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15592624
• MDR Text Key: 301646025
• Report Number: 15592624
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)230430(10)27235181
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2022

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: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 27235181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Male
• Patient Weight: 69 KG