• 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
Model Number 400SMTHXSFT0306
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Event Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, a smart coil was reported to be stiff and could not be fully inserted into the aneurysm.It was also reported that the smart coil kicked the microcatheter out of the target location.After several attempts to implant the same smart coil, the same issue continued to occur.Therefore, the smart coil was removed.Next, the same issue occurred with the next two smart coils.Therefore, these smart coils were also removed.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
 
Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-02505, 3005168196-2021-02507.
 
Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.This damage likely contributed to the embolization coil being stiff during the procedure.The introducer sheath was not returned for evaluation; therefore, during the functional test, the device was sheathed with a demonstration introducer sheath during functional testing, then the smart coil could not advance out of the introducer sheath due to the offset coil winds.Evaluation of the returned smart coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.This damage likely contributed to the embolization coil being stiff during the procedure.During functional testing, the device was able to advance through its introducer sheath and a demonstration microcatheter without issue.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath without issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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 numbers: 1.3005168196-2021-02505.2.3005168196-2021-02507.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12771465
MDR Text Key283312874
Report Number3005168196-2021-02506
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548015781
UDI-Public00814548015781
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K160832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/01/2005,12/29/2021
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
Device Model Number400SMTHXSFT0306
Device Catalogue Number400SMTHXSFT0306
Device Lot NumberF104916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 10/15/2021
Initial Date FDA Received11/08/2021
Supplement Dates Manufacturer Received12/17/2021
Supplement Dates FDA Received12/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-