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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-A
Medical Device Problem Code Difficult to Advance (2920)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/22/2015
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: 3005168196-2016-00082.The hospital disposed of the device.
 
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician had difficulty advancing two ruby coils through the hub of another manufacturer's microcatheter.
 
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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 Key5384642
Report Number3005168196-2016-00083
Device Sequence Number11005693
Product Code HCG
UDI-Device Identifier00814548013114
UDI-Public00814548013114
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
Report Date (Section B) 12/22/2015
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 Physician
Device Expiration Date12/31/2019
Device Catalogue NumberRBY4C0201-A
Device Lot NumberF61669
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/21/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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