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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
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 01/24/2018
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital disposed of the device.
 
Event Description
During preparation for a coil embolization procedure, the pusher wire of a penumbra smart coil (smart coil) became bent upon removal from the packaging.The damage to the smart coil occurred prior to use, and therefore it was not used in the procedure.The procedure was completed using a new smart coil.
 
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Brand Name
PENUMBRA SMART 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 Key7308017
MDR Text Key101486690
Report Number3005168196-2018-00456
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeUS
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 02/06/2018
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/06/2018
Initial Date FDA Received03/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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