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

Model Number H7495551110

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 04/08/2019

Event Type  malfunction  

Event 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
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8607978
• MDR Text Key: 144987494
• Report Number: 8607978
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: (01)08714729875758
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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: 22498396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 104