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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
Model Number RBY4C0204-A
Medical Device Problem Code Premature Separation (4045)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/07/2021
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.
 
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil unintentionally detached; therefore, it was removed.No additional information regarding the completion of the procedure was provided.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 Key12301282
Report Number3005168196-2021-01780
Device Sequence Number3761177
Product Code HCG
UDI-Device Identifier00814548013138
UDI-Public00814548013138
Combination Product (Y/N)Y
Initial Reporter CountryFR
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) 08/10/2021
Report Date (Section F) 01/01/2005
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 Model NumberRBY4C0204-A
Device Catalogue NumberRBY4C0204
Device Lot NumberF98440
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2021
Initial Report FDA Received Date08/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age49 YR
Date Report Sent to FDA01/01/2005
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