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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
Catalog Number PNML6F088804
Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Patient Problems Ischemia (1942); Device Embedded In Tissue or Plaque (3165)
Event Date 11/02/2015
Event Type  Injury  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a large aneurysm pipeline procedure using a neuron max 6f 088 long sheath (neuron max). During the procedure, the physician had difficulty inserting the neuron max and used a large dilator to pre-dilate the vessel and then smoothly inserted the neuron max in the patient; however, the physician noticed that the marker band of the neuron max fell off and traveled up to the m1 vessel in the middle cerebral artery and became lodged. After several unsuccessful attempts to retrieve the marker band using another manufacturer's device, the physician decided to use a stent to keep the marker band in place since the patient's blood flow in the brain did not seem to be disrupted by the marker band. During the early morning hours of the next day, the patient demonstrated stroke signs of right-sided hemiplegia. The patient was brought into the angio suite and there was no sign of a large vessel occlusion. Since the patient's stroke, post-procedure, the patient was being treated and had hemiplegic speech impairment. The patient's condition improved from the initial onset of the stroke symptoms but the patient was still experiencing right-sided hemiplegia and was aphasic. As of 12/01/2015, the patient is still recovering and is doing slightly better.

 
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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 (Section G)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key5258906
MDR Text Key32450928
Report Number3005168196-2015-01210
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date07/31/2018
Device Catalogue NumberPNML6F088804
Device LOT NumberF65107
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/30/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/01/2015 Patient Sequence Number: 1
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