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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
Medical Device Problem Codes Device Damaged Prior to Use (2284); Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/03/2018
Type of Reportable Event Malfunction
Additional 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 or Problem 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
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key8206910
Report Number3005168196-2018-02549
Device Sequence Number16673783
Product Code HCG
UDI-Device Identifier00814548013114
UDI-Public00814548013114
Combination Product (Y/N)Y
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K120330
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/03/2018
Report Date (Section F) 01/01/2005
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
Operator of Device Health Professional
Device Expiration Date09/21/2023
Device Catalogue NumberRBY4C0201
Device Lot NumberF65814
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2018
Initial Report FDA Received Date12/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Date Report Sent to FDA01/01/2005
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