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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number H7495551110
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2020
Event Type  malfunction  
Event 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 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.
 
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Brand Name
COMET
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10642314
MDR Text Key210225004
Report Number10642314
Device Sequence Number1
Product Code DXO
UDI-Device Identifier08714729875758
UDI-Public(01)08714729875758(17)220730(10)25792011
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Model NumberH7495551110
Device Lot Number25792011
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2020
Event Location Hospital
Date Report to Manufacturer10/07/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/07/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age29930 DA
Patient Weight89
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