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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 4004C0615
Medical Device Problem Codes Detachment Of Device Component (1104); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.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
While preparing for a coil embolization procedure, the physician opened the packaging of the first penumbra coil 400 (pc400) and then attempted to remove the coil from its dispenser; however, the pc400 was already exposed and had unintentionally detached.Therefore, the pc400 was not used in the procedure and did not come into contact with the patient.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 Key6958449
Report Number3005168196-2017-01789
Device Sequence Number683299
Product Code HCG
UDI-Device Identifier00814548010885
UDI-Public00814548010885
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K120330
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/19/2017
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 Expiration Date08/20/2024
Device Catalogue Number4004C0615
Device Lot NumberF71243
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/19/2017
Initial Report FDA Received Date10/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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