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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 400SMTSTD0830
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/24/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-00711.The hospital disposed of the device.
 
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, two smart coils fell onto the floor prior to being used.Therefore, both coils were not used for the procedure and did not enter the patient's body.The procedure was completed using new smart coils.
 
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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 Key5690165
Report Number3005168196-2016-00712
Device Sequence Number451610
Product Code HCG
UDI-Device Identifier00814548014524
UDI-Public00814548014524
Combination Product (Y/N)N
Initial Reporter CountryPO
PMA/510(K) Number
K160832
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/24/2016
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 Health Professional
Device Expiration Date08/29/2020
Device Catalogue Number400SMTSTD0830
Device Lot NumberF65545
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2016
Initial Report FDA Received Date05/31/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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