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

Model Number	H7495551110
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ffr wire fractured with part of the wire remaining in lcx.Unsuccessful attempts were made to remove the fractured piece of the wire.The patient was scheduled for a bypass surgery the next day in which the piece was removed.Manufacturer response for transducer, pressure, catheter tip, comet (per site reporter).The field representative was notified of the issue by the physician.No feedback has been received at this time.Further correspondence will be shared as it becomes available.

• Brand Name: COMET
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8607978
• Report Number: 8607978
• Device Sequence Number: 19378140
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: (01)08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2019
• Report Date (Section F): 04/22/2019

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: 22498396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 104
• Date Report Sent to FDA: 04/22/2019