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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 PNML6F088904-R
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
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: 3005168196-2021-01483, 3005168196-2021-01484.
 
Event Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max) and a penumbra system ace 68 reperfusion catheter (ace68). During the procedure, the physician experienced resistance while attempting to advance the ace68 through the distal end of the neuron max. Therefore, the ace68 was removed. Afterwards, the physician attempted to advance a new ace68 through the neuron max; however the same issue occurred. Therefore, the ace68 and neuron max were removed. The procedure was completed using a new ace68 and new neuron max. 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 Key12132111
MDR Text Key260481534
Report Number3005168196-2021-01482
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
K111380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPNML6F088904-R
Device Catalogue NumberPNML6F088904
Device Lot NumberH11095
Was Device Available for Evaluation? Yes
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 Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2021
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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