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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 4004C1845
Medical Device Problem Codes Out-Of-Box Failure (2311); Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/12/2018
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
During preparation for a coil embolization procedure, the hospital technician inadvertently dropped the peunumbra coil 400 (pc400) on the floor upon removal from the packaging.The reported issue was found prior to use and therefore, the pc400 was not used in 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 Key7498950
Report Number3005168196-2018-00970
Device Sequence Number160342
Product Code HCG
UDI-Device Identifier00814548011110
UDI-Public00814548011110
Combination Product (Y/N)N
Initial Reporter StateMA
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 Other
Type of Report Initial
Report Date (Section B) 04/12/2018
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 Expiration Date04/03/2019
Device Catalogue Number4004C1845
Device Lot NumberA20436
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/12/2018
Initial Report FDA Received Date05/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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