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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 RBY4C0406
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/24/2018
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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a coil embolization procedure, the ruby coil was dropped on the floor when it was handing off to the hospital staff upon removal from the packaging.The ruby coil was dropped prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed 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 Key7622411
Report Number3005168196-2018-01229
Device Sequence Number11160544
Product Code HCG
UDI-Device Identifier00814548013169
UDI-Public00814548013169
Combination Product (Y/N)N
Initial Reporter StateNY
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) 05/25/2018
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 Date11/26/2025
Device Catalogue NumberRBY4C0406
Device Lot NumberF80731
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2018
Initial Report FDA Received Date06/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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