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

Model Number H7495551110

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

Elderly female presented to emergency department with chest pain and unstable angina.While having a heart cath, attempted with (2 different devices) the comet wire to apprehend diastolic hyperemia-free ratio/fractional flow reserve readings (dfr/ffr) reading and although both wires crossed lesion, neither gave dfr/ffr.Waveforms present but no number reading.Please note that there were 2 products used.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10808643
• MDR Text Key: 215288428
• Report Number: 10808643
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: (01)08714729875758(17)220724(10)25766654
• 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: 10/29/2020

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: H7495551110
• Device Lot Number: 25766654
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2020
• Event Location: Other
• Date Report to Manufacturer: 11/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 57