POLARIS® SPV KIT PREATTACHED / BO19-10
Report
- Report Number
- 3001587388-2026-00009
- Event Type
- Injury
- Date Received
- February 9, 2026
- Report Date
- February 9, 2026
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- UDI-DI
- 03760124131277
- PMA / PMN Number
- K141227
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INFECTION WAS TRACED TO THE SURGERY PROCEDURE; THE SHUNT HAS BEEN REMOVED BY PRECAUTION. THE ROOT CAUSE OF THE INFECTION IS LINKED TO THE SURGERY PROCEDURE AND THE SHUNT WAS NOT IMPLICATED. ALL THESE INFORMATION HAVE BEEN CONFIRMED BY THE HOSPITAL AND THE INCIDENT WAS CONSIDERED AS PREDICTIBLE. THE INCIDENT HAS NOT BEEN REPORTED BY THE HOSPITAL, SINCE SOPHYSA WAS FOLLOWING THE PROCEDURE FOR CLINICAL INVESTIGATION DIRECTLY AT THE HEALTHCARE FACILITY. THE INCIDENT WAS THEREFORE REPORTED BY THE SOPHYSA TEAM OUT THERE.
A 5-MONTH OLD BABY HAD AN INFECTION FOLLOWING THE SURGERY AND THE DECISION TO EXPLANT A POLARIS VALVE HAS BEEN TAKEN BY THE NEUROSURGEON, A TEMPORARY EXTERNAL DERIVATION WAS PLACED WHILE AWAITING FOR THE IMPLANTATION OF A NEW SOPHYSA VALVE : POLARIS 24 (SPV24). THIS IMPLANTATION WAS PERFORMED DURING CLINICAL INVESTIGATION AND THE SPV24 VALVE IS NOT YET MARKETED BY SOPHYSA. THE INFECTION WAS TRACED TO SURGERY PROCEDURE, THE SHUNT HAS BEEN REMOVED BY PRECAUTION. ALL THESE INFORMATION HAVE BEEN CONFIRMED BY THE HOSPITAL AND THE INCIDENT WAS CONSIDERED AS PREDICTIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351588 | POLARIS® SPV KIT PREATTACHED / BO19-10 | POLARIS® SPV KIT PREATTACHED / BO19-10 | JXG | SOPHYSA | SPV-2010 | 03760124131277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO | Unknown | Other |