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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 RBY2C1660
Medical Device Problem Codes Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.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 discarded the device.
 
Event or Problem Description
During preparation for a coil embolization procedure, the hospital technician accidentally detached the ruby coil (ruby coil) upon removal from the packaging.The ruby coil detached prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed using new ruby coils.
 
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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 Key7452543
Report Number3005168196-2018-00833
Device Sequence Number1195796
Product Code HCG
UDI-Device Identifier00814548013053
UDI-Public00814548013053
Combination Product (Y/N)N
Initial Reporter StateFL
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) 03/26/2018
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 Radiologic Technologist
Device Expiration Date06/19/2025
Device Catalogue NumberRBY2C1660
Device Lot NumberF77805
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2018
Initial Report FDA Received Date04/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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