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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 RBY2C0305
Medical Device Problem Code Failure to Advance (2524)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/23/2017
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital disposed of the device.
 
Event or Problem Description
The patient was undergoing a coil embolization using ruby coils.During the procedure, while attempting to advance a ruby coil through another manufacturer's microcatheter, the physician did not mention any resistance but was unable to advance the coil through the microcatheter.Therefore, the ruby coil was removed and the procedure was completed using an additional coil and the same microcatheter.There was no report of an adverse effect to the patient.
 
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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 Key6512533
Report Number3005168196-2017-00629
Device Sequence Number612894
Product Code HCG
UDI-Device Identifier00814548012810
UDI-Public00814548012810
Combination Product (Y/N)N
Initial Reporter StateMA
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) 03/24/2017
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 Physician
Device Catalogue NumberRBY2C0305
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/24/2017
Initial Report FDA Received Date04/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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