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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 RBY2C0630
Medical Device Problem Codes Detachment Of Device Component (1104); Mechanical Jam (2983)
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 procedure to treat a gastrointestinal bleeding from the superior mesenteric artery using ruby coils.During the procedure, while advancing through a lantern delivery microcatheter, a ruby coil unintentionally detached within the lantern.Therefore the physician removed the lantern with the detached ruby coil inside and completed the procedure using a new microcatheter and new coils.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 Key6501644
Report Number3005168196-2017-00625
Device Sequence Number1201588
Product Code HCG
UDI-Device Identifier00814548012940
UDI-Public00814548012940
Combination Product (Y/N)N
Initial Reporter StateRI
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 Physician
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 NumberRBY2C0630
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 Date04/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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