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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 RBY2C0930-A
Medical Device Problem Codes Contamination (1120); Use of Device Problem (1670)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/12/2016
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.This report is associated with mfr report number: 3005168196-2016-00305.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a coil embolization procedure, two ruby coils touched a non-sterile item after the hospital technologist removed the coils from their dispenser hoop.The ruby coils became non-sterile prior to use and therefore, they were not used for 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 Key5490706
Report Number3005168196-2016-00304
Device Sequence Number11049702
Product Code HCG
UDI-Device Identifier00814548012995
UDI-Public00814548012995
Combination Product (Y/N)N
Initial Reporter StateNV
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) 02/12/2016
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 Other
Device Expiration Date09/21/2023
Device Catalogue NumberRBY2C0930-A
Device Lot NumberF65791
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2016
Initial Report FDA Received Date03/09/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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