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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH DQY

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PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH DQY Back to Search Results
Model Number PNML6F088904M
Device Problems Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  Malfunction  
Manufacturer Narrative

The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a medical procedure in the middle cerebral artery (mca) to treat an arteriovenous malformation (avm) using a neuron max 6f 088 long sheath (neuron max). During the procedure, the physician experienced resistance while inserting a dilator into a neuron max and decided to remove the neuron max. Upon removal, it was noticed that the neuron max was stretched at the distal end and kinked at the proximal end. The procedure was completed using a non-penumbra sheath. There was no report of an adverse effect to the patient.

 
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Brand NameNEURON MAX 6F 088 LONG SHEATH
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key12303684
MDR Text Key265993475
Report Number3005168196-2021-01783
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeIN
PMA/PMN NumberK111380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,09/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPNML6F088904M
Device Catalogue NumberPNML6F088904M
Device LOT NumberH10831
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/28/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received08/25/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/19/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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