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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.
 
Manufacturer Narrative
The returned valve was found clean, with the presence of liquid drops.The catheter was clean and was already cut approximately 5cm from the connector.A suture was found on the other end of the catheter which also contains csf drops.Depth testing was performed on the valve: obstruction testing with air and alcohol was negative, impermeability testing to air and to alcohol was positive, setting programming assessment was eventless, and pressure setting control provided complying values.No issues were found during these tests, and the default reported by the user was not confirmed.It was not possible to conclude on the origin of the incident reported as the device was found in conformity within manufacturing standards.
 
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 Name
POLARIS SPV KIT PREATTACHED/BO19-10
Type of Device
SPV-2010
Manufacturer (Section D)
SOPHYSA
5 rue guy moquêt
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
PMA/PMN Number
K141227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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 Health Professional
Device Model NumberSPV-2010
Device Lot NumberH030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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