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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD
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PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD Back to Search Results
Catalog Number 400SMTXSFT2H06
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/20/2017
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.This report is associated with mfr report number: 3005168196-2017-02201.The device is not available for return.
 
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right posterior cerebral artery (pca) using penumbra smart coils (smart coils).During the procedure, two smart coils would not go into the aneurysm due to positioning.There was no report of an adverse effect to the patient.
 
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Brand Name
PENUMBRA SMART COIL
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7105126
Report Number3005168196-2017-02200
Device Sequence Number13797704
Product Code HCG
UDI-Device Identifier00814548015330
UDI-Public00814548015330
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K160832
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) 11/15/2017
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 Catalogue Number400SMTXSFT2H06
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2017
Initial Report FDA Received Date12/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age65 YR
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