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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 RBY2C1035
Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 05/25/2017
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was discarded by the hospital.
 
Event Description
During preparation for a coil embolization procedure, the technician inadvertently bent a ruby coil on the back table.The damage to the ruby coil occurred prior to use; therefore, it was not used in the procedure.The procedure was completed using a new ruby 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 Key6664711
MDR Text Key78397761
Report Number3005168196-2017-00996
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548013008
UDI-Public00814548013008
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 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRBY2C1035
Device Lot NumberF73578
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2017
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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