MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

Comet wire broke when physician tried to remove wire from coronary.Tip of wire stuck on stent in left anterior descending artery (lad).Physician stented over wire to hold in place against wall of vessel, however tip of wire remains freely inside coronary due to being inside left main.Location: catheter lab.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1234
• MDR Report Key: 8353470
• MDR Text Key: 136605504
• Report Number: 8353470
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: (01)08714729875758(17)200726(10)22433553
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7495551110
• Device Lot Number: 22433553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2019
• Date Report to Manufacturer: 02/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2019
• Type of Device Usage: N
• Patient Sequence Number: 1