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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 RBY2C0825
Medical Device Problem Codes Unraveled Material (1664); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/31/2016
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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was not returned to manufacturer.
 
Event or Problem Description
During preparation for a coil embolization procedure, a ruby coil unraveled on the tray prior to use.The damage to the ruby coil was noticed prior to use.
 
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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 Key6723348
Report Number3005168196-2017-01213
Device Sequence Number187946
Product Code HCG
UDI-Device Identifier00814548012971
UDI-Public00814548012971
Combination Product (Y/N)N
Initial Reporter StateMI
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/20/2017
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 Date11/16/2023
Device Catalogue NumberRBY2C0825
Device Lot NumberF66560
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/20/2017
Initial Report FDA Received Date07/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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