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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 RBY2C1240
Medical Device Problem Code Failure to Advance (2524)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/15/2016
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 numbers: 3005168196-2017-00143, 3005168196-2017-00144, 3005168196-2017-00146.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a coil embolization procedure, the hospital staff was unable to advance four ruby coils pass their friction locks and out of their introducer sheaths.Therefore, the four ruby coils were not used for the procedure and the procedure was completed using additional 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 Key6301750
Report Number3005168196-2017-00145
Device Sequence Number19109140
Product Code HCG
UDI-Device Identifier00814548013015
UDI-Public00814548013015
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K120330
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/15/2016
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 Health Professional
Device Expiration Date03/23/2024
Device Catalogue NumberRBY2C1240
Device Lot NumberF68676
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/15/2016
Initial Report FDA Received Date02/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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