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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA NEURON MAX 088 6F 088 NEURON MAX LONG SHEATH

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PENUMBRA NEURON MAX 088 6F 088 NEURON MAX LONG SHEATH Back to Search Results
Catalog Number PNML6F08804
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problems Hemorrhage, Subarachnoid (1893); Paresis (1998); Hernia (2240)
Event Date 01/05/2018
Event Type  Injury  
Event Description

Pt underwent an endovascular coiling of a ruptured right internal carotid artery aneurysm in (b)(6) 2017. She was brought back to the same facility for elective endovascular flow diverting pipeline stent embolization for treatment of the residual right lateral carotid artery aneurysm on (b)(6) 2018. During the procedure, a neuron max 6 f 80 cm sheath taken over penumbra select 5f diagnostic catheter from the right groin into the right common carotid artery. The physician noticed the distal tip of the radio-opaque marker of the neuron max sheath had separated from the catheter and had migrated into the right middle cerebral artery. During the attempt to retrieve the radio-opaque marker, the posterior division of the right middle cerebral artery was dissected with subsequent subarachnoid hemorrhage noted. The neuro interventionalist aborted the procedure, left the marker remaining within the vessel, and reversed the heparin. The pt was taken to icu intubated on a mechanical ventilator. Ct revealed herniation of the brain; therefore, an emergency right hemi-craniectomy was performed on (b)(6) 2018. Currently the pt is being weaned off the ventilator and is following simple commands with left hemiparesis.

 
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Brand NameNEURON MAX 088
Type of Device6F 088 NEURON MAX LONG SHEATH
Manufacturer (Section D)
PENUMBRA
alameda CA
MDR Report Key7186581
MDR Text Key97338959
Report NumberMW5074554
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/07/2018
Device Catalogue NumberPNML6F08804
Device LOT NumberF66825
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/11/2018 Patient Sequence Number: 1
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