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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 8900
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2020
Event Type  malfunction  
Event Description
It was reported that the package was not sealed.During a diagnostic left heart cath and while outside the patient, it was noticed that a comet pressure guidewire package was not sealed.The comet device was not used and the procedure was successfully completed.No patient complications resulted in relation to this event.
 
Event Description
It was reported that the package was not sealed.During a diagnostic left heart cath and while outside the patient, it was noticed that a comet pressure guidewire package was not sealed.The comet device was not used and the procedure was successfully completed.No patient complications resulted in relation to this event.It was later reported that there was only one comet device involved.The comet sealed package issue was reported under parent record 2134265-2020-15662.Report 2134265-2020-15661 was filed in error.
 
Event Description
It was reported that the package was not sealed.During a diagnostic left heart cath and while outside the patient, it was noticed that a comet pressure guidewire package was not sealed.The comet device was not used and the procedure was successfully completed.No patient complications resulted in relation to this event.It was later reported that there was only one comet device involved.The comet sealed package issue was reported under parent record (b)(6).Report 12994259 was filed in error.
 
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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 Key10837726
MDR Text Key216189146
Report Number2134265-2020-15662
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
PMA/PMN Number
K151610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8900
Device Catalogue Number8900
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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