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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD
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PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD Back to Search Results
Catalog Number 4004C0513
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/21/2016
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 device is not available for return.
 
Event or Problem Description
While preparing a penumbra coil 400 (pc400) for a coil embolization procedure, the radiologic technologist inadvertently dropped the pc400 onto the floor prior to inserting it into the microcatheter.The pc400 was dropped prior to its use and therefore, was not used for the procedure.The procedure was completed using a new pc400.
 
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Brand Name
PENUMBRA COIL 400
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key6672200
Report Number3005168196-2017-01010
Device Sequence Number197780
Product Code HCG
UDI-Device Identifier00814548010861
UDI-Public00814548010861
Combination Product (Y/N)N
Initial Reporter StateTX
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) 06/21/2016
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 Radiologic Technologist
Device Catalogue Number4004C0513
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2016
Initial Report FDA Received Date06/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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