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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
Device Problems Retraction Problem (1536); Out-Of-Box Failure (2311); Material Protrusion/Extrusion (2979)
Patient Problem No Patient Involvement (2645)
Event Date 07/06/2017
Event Type  malfunction  
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 Description
While attempting to remove a ruby coil from its dispenser hoop for a coil embolization procedure, the hospital staff noticed that the ruby coil introducer sheath was protruding out of the dispenser hoop.The ruby coil was unsheathed and could not be re-sheathed.The ruby coil was set aside and the procedure was completed using another coil.
 
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Brand Name
RUBY COIL
Type of Device
HCG,KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key6744024
MDR Text Key81143451
Report Number3005168196-2017-01307
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548012940
UDI-Public00814548012940
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/06/2017
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
Device Operator Health Professional
Device Catalogue NumberRBY2C0630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/06/2017
Initial Date FDA Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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