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	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease, recurrent ventricular tachycardia, atrial fibrillation.While having and outpatient heart catheterization, a comet fractional flow reserve (ffr) pressure wire was inserted.The wire failed to sync to the ffr link.The superuser did trouble shoot without resolve.A new comet wire was used without issue.No known harm to the patient.
Event or Problem Description
Elderly male with history of coronary artery disease, recurrent ventricular tachycardia, atrial fibrillation.While having and outpatient heart catheterization, a comet fractional flow reserve (ffr) pressure wire was inserted.The wire failed to sync to the ffr link.The superuser did trouble shoot without resolve.A new comet wire was used without issue.No known harm to the 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: 10642314
• Report Number: 10642314
• Device Sequence Number: 2631449
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: (01)08714729875758(17)220730(10)25792011
• 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,Followup
• Report Date (Section B): 09/25/2020
• Report Date (Section F): 09/25/2020

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: 25792011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 89
• Date Report Sent to FDA: 09/25/2020