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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA POLARIS SPV KIT PREATTACHED/BO19-10 SPV-2010

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SOPHYSA POLARIS SPV KIT PREATTACHED/BO19-10 SPV-2010 Back to Search Results
Model Number SPV-2010
Device Problem Complete Blockage (1094)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2021
Event Type  malfunction  
Manufacturer Narrative
Pending device return for depth analysis. A follow up report will be sent thereafter.
 
Event Description
Within the context of peritoneal internal shunt derivation system revision, a new sophysa polaris valve system was implanted. At the end of the procedure, it was noticed the cerebrospinal fluid was not drained. Another new polaris valve was implanted, leading into 30-minute additional time.
 
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Brand NamePOLARIS SPV KIT PREATTACHED/BO19-10
Type of DeviceSPV-2010
Manufacturer (Section D)
SOPHYSA
5 rue guy moquêt
orsay, 91400
FR 91400
Manufacturer (Section G)
SOPHYSA
rue sophie germain
besançon, 25000
FR 25000
Manufacturer Contact
hanta ranaivoson
5 rue guy moqêt
orsay, 91400
FR   91400
MDR Report Key11547561
MDR Text Key244893608
Report Number3001587388-2021-21134
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPV-2010
Device Lot NumberH030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
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: 03/22/2021 Patient Sequence Number: 1
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