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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD
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PENUMBRA, INC. RUBY COIL; HCG, KRD Back to Search Results
Catalog Number RBY4C0201
Device Problems Device Damaged Prior to Use (2284); Device Handling Problem (3265)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.
 
Event Description
During preparation for a coil embolization procedure, a ruby coil was accidentally contaminated.The ruby coil was contaminated before use and therefore, the procedure was performed using a new ruby coil.
 
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Brand Name
RUBY COIL
Type of Device
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key8206910
MDR Text Key131774227
Report Number3005168196-2018-02549
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548013114
UDI-Public00814548013114
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K120330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/21/2023
Device Catalogue NumberRBY4C0201
Device Lot NumberF65814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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