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

Catalog Number PNML6F08804

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Infarction, Cerebral (1771); Hematoma (1884); Hemorrhage/Bleeding (1888); Paresis (1998)

Event Date 01/05/2018

Event Type  Injury  

Event Description

Patient 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 internal 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 attempts to retrieve the radio-opaque marker, the posterior division of the r 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 patient 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 patient is being weaned off the ventilator and is following simple commands with left hemiparesis.On (b)(6) 2018 - ct brain - intraparenchymal hemorrhage right frontal lobe with adjacent subarachnoid hemorrhage and 2 mm herniation (b)(6) 2018 - cp brain - acute right sided middle cerebral artery infarct (b)(6) 2018 - ct brain - stable right intraparenchymal hematoma and right middle cerebral artery infarct with decrease in midline shift.

• Brand Name: 6F 088 NEURON MAX LONG SHEATH
• Type of Device: 6F 088 NEURON MAX LONG SHEATH
• Manufacturer (Section D): PENUMBRA; alameda CA
• MDR Report Key: 7181614
• MDR Text Key: 97085223
• Report Number: MW5074517
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Catalogue Number: PNML6F08804
• Device Lot Number: F66825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 86