• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH DQY Back to Search Results
Catalog Number PNML6F088904M
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893)
Event Date 04/07/2017
Event Type  Injury  
Manufacturer Narrative
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report number: 3005168196-2017-01284. The hospital disposed of the device.
 
Event Description
On (b)(6) 2017, the patient underwent 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 3max reperfusion catheter (3maxc). It was noted that the patient presented to the hospital with a baseline national institutes of health stroke scale (nihss) score of 20. The patient was directly treated with mechanical thrombectomy (no iv rt-pa was administered). During the procedure, the physician placed a neuron max in the target vessel then completed the first pass using a penumbra system ace 68 reperfusion catheter (ace68) which resulted in a thrombolysis in cerebral infarction (tici) score of 0. The physician then used a 3maxc to aspirate in the distal vasculature. After completing the second pass, the patient¿s tici score was 3. Subsequently, a follow-up non-contrast computerized tomography (ncct) performed 24-hours after the procedure revealed evidence of intracranial hemorrhage (hemorrhage infarction type 2 (hi-2)) and subarachnoid hemorrhage. This adverse event of intracranial hemorrhage (ich) with subarachnoid hemorrhage (sah) was resolved with no additional action taken, and the patient was discharged on (b)(6) 2017 with a nihss score of 6 and transferred to a reference hospital. The intracranial hemorrhage (ich) with subarachnoid hemorrhage (sah) was adjudicated to be of moderate severity with an unrelated relationship to the ace68, uncertain relationship to the other penumbra devices, uncertain relationship to the non-penumbra devices, uncertain relationship to the angiographic procedure, and uncertain relationship to the index stroke.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6758616
MDR Text Key81561692
Report Number3005168196-2017-01283
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeSP
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 07/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/18/2019
Device Catalogue NumberPNML6F088904M
Device Lot NumberF72095
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2016
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: 08/01/2017 Patient Sequence Number: 1
-
-