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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL DETACHMENT HANDLE; HCG, KRD

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PENUMBRA, INC. PENUMBRA SMART COIL DETACHMENT HANDLE; HCG, KRD Back to Search Results
Catalog Number SCH1
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
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.This report is associated with mfr report number: 3005168196-2018-01043.The hospital discarded the device.
 
Event Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and two penumbra smart coil detachment handles (handles).During the procedure, the physician successfully placed two coils using a non-penumbra microcatheter.The physician then advanced and attempted to detach a smart coil in the target location, however the smart coil did not detach, despite three attempts with the handle.The physician, therefore, attempted to detach the smart coil using a new handle, however the smart coil still did not detach.The smart coil was therefore removed, and the procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.
 
Manufacturer Narrative
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: 3005168196-2018-01043.
 
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Brand Name
PENUMBRA SMART COIL DETACHMENT HANDLE
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 Key7538790
MDR Text Key109104787
Report Number3005168196-2018-01042
Device Sequence Number1
Product Code HCG
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K160832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,04/23/2018
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 Physician
Device Expiration Date12/13/2022
Device Catalogue NumberSCH1
Device Lot NumberF81012
Was Device Available for Evaluation? No
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 04/23/2018
Initial Date FDA Received05/23/2018
Supplement Dates Manufacturer Received01/14/2005
Supplement Dates FDA Received10/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2017
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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