Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD Back to Search Results
Catalog Number 400SMTXSFT0203
Medical Device Problem Codes Bent (1059); Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/11/2016
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.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a coil embolization procedure, a penumbra smart coil (smart coil) pusher assembly became bent while the hospital staff was removing the coil from the packaging hoop.The smart coil pusher assembly became bent prior to use and therefore, the smart coil was not used for the procedure.The procedure was completed using a new smart coil.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PENUMBRA SMART COIL
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key5645573
Report Number3005168196-2016-00648
Device Sequence Number190375
Product Code HCG
UDI-Device Identifier00814548015279
UDI-Public00814548015279
Combination Product (Y/N)N
Initial Reporter StateMN
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) 04/11/2016
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 Date11/08/2020
Device Catalogue Number400SMTXSFT0203
Device Lot NumberF66414
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2016
Initial Report FDA Received Date05/10/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-