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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 RBY4C0201
Medical Device Problem Codes Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/27/2017
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.
 
Event or Problem Description
During preparation for a coil embolization procedure, the radiologic technologist inadvertently kinked a ruby coil detachment zone while removing the ruby coil from its dispenser hoop.The detachment zone became kinked prior to use and therefore, the ruby coil was not used in the procedure.The procedure was completed using another 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 Key7043348
Report Number3005168196-2017-02066
Device Sequence Number11238139
Product Code HCG
UDI-Device Identifier00814548013114
UDI-Public00814548013114
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/27/2017
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 Radiologic Technologist
Device Expiration Date10/09/2024
Device Catalogue NumberRBY4C0201
Device Lot NumberF72006
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2017
Initial Report FDA Received Date11/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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