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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Patient was given 6000u heparin in preparation for dfr with comet wire.When tech was starting equipment for dfr, equipment would not function.Biomed called by business and technical manager.Waited approx 10-15 minutes to try to get dfr functioning.Physician decided to forgo dfr due to equipment not functioning with no clear indication of when it would work again.Therefore, patient received heparin that they did not need due to equipment malfunction.

• Brand Name: COMET II PRESSURE GUIDEWIRE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15619285
• MDR Text Key: 301901694
• Report Number: 15619285
• Device Sequence Number: 1
• Product Code: DXO
• 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: 09/30/2022

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
• 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: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White