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

Model Number	H7495551110
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upper-middle aged female with history of hypertension, diabetes and acute onset of chest pressure.While having a heart cath, there was no diastolic hyperemia-free ratio/fractional flow reserve (dfr/ffr) reading given.Possible software malfunction.No known harm to patient.

• Brand Name: COMET
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10835545
• Report Number: 10835545
• Device Sequence Number: 3799064
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: (01)08714729875758(17)220819(10)25887926
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/05/2020
• Report Date (Section F): 11/05/2020

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
• Operator of Device: Health Professional
• Device Model Number: H7495551110
• Device Lot Number: 25887926
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1
• Patient Weight: 92
• Date Report Sent to FDA: 11/05/2020