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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 03/01/2016
Event Type  Injury  
Manufacturer Narrative
The product was not returned for evaluation. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Potential adverse events in the labeling with the neuron max system include, but are not limited to, hematoma or hemorrhage at puncture site, vessel spasm, thrombosis, dissection, or perforation, intracranial hemorrhage, ischemia, including death. Therefore, it was determined that the reported adverse events were anticipated complications. The product lot number was not provided, therefore, the manufacturing records could not be reviewed. This report is associated with mfr report numbers: 3005168196-2020-01185, 3005168196-2020-01186, and 3005168196-2020-01187.
 
Event Description
Penumbra inc. Became aware on 15-jul-2020 during its post-market surveillance activities of a journal article titled, ¿aspiration thrombectomy as the first-line treatment of m2 occlusions. " (harsany et al. , 2020). It was reported that 82 patients with acute ischemic stroke and isolated m2 segment occlusions were treated in a cerebrovascular stroke center using the neuron max 6f 088 long sheath (neuron max) and either the penumbra system 4max reperfusion catheter (4maxc), the penumbra system ace 60 reperfusion catheter (ace60), or the penumbra system ace 64 reperfusion catheter (ace64). All data was collected from a single center between march 2016 and june 2019. Among all patients, five experienced symptomatic intracranial hemorrhage (sich). However, there is no allegation within the article that a malfunction of the penumbra system occurred. The relationship between the penumbra devices and the sich was not specified. It was not reported whether any action was taken to treat the cases of sich. It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints. Therefore, this report addresses all adverse events within this literature source.
 
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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 Key10405253
MDR Text Key203121874
Report Number3005168196-2020-01184
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeLO
PMA/PMN Number
K111380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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 Received07/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/13/2020 Patient Sequence Number: 1
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