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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 RBY2C0420
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/29/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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 numbers: 3005168196-2017-01255, 3005168196-2017-01256.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a coil embolization procedure, the nurse inadvertently knocked the back table over and consequently, three ruby coils became contaminated.The ruby coils became contaminated prior to use and therefore, were not used for the procedure.The procedure was completed using four 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 Key6744818
Report Number3005168196-2017-01257
Device Sequence Number831809
Product Code HCG
UDI-Device Identifier00814548012865
UDI-Public00814548012865
Combination Product (Y/N)N
Initial Reporter StateWA
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) 06/29/2017
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 Nurse
Device Expiration Date05/31/2023
Device Catalogue NumberRBY2C0420
Device Lot NumberF63976
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/29/2017
Initial Report FDA Received Date07/26/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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