MAUDE Adverse Event Report: SOPHYSA SIPHONX; SIPHONX GRAVITATIONAL ANTI-SIPHON DE

Model Number	SX-200
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sophysa has received the returned piece and the product in question has been examined according to our quality control procedure: visual check: the valve returned is clean without deposit inside.There are some marks on the outlet connector but no visual defect are visible in the intern mechanism.Functional control: flushing air or alcohol through the device remains possible and the ruby ball is not stuck on its seat.Pressure control: the pressures measured conform to the specification at all angle positions.In conclusion, the product meets all its specifications.We could not find any mechanical failure with the returned device.Antisiphon is working regarding the angle with vertical axis.Dysfunction feeling might be related to the additional resistance provided by the gravitational antisiphon device.
Event or Problem Description
A patient (sex and age are unknown) was implanted with a polaris valve and an anti-siphon device siphonx on (b)(6) 2016.The patient developed hc symptoms (headache, vomiting) and enlarged ventricles.On (b)(6) 2016 a shunt revision identified the malfunction as due to the siphonx.

• Brand Name: SIPHONX
• Common Device Name: SIPHONX GRAVITATIONAL ANTI-SIPHON DE
• Manufacturer (Section D): SOPHYSA; 5, rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 5905984
• Report Number: 3001587388-2016-16308
• Device Sequence Number: 18949432
• Product Code: JXG
• UDI-Device Identifier: 03760124131697
• UDI-Public: 3760124131697
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K091328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/01/2020
• Device Model Number: SX-200
• Device Catalogue Number: SX-200
• Device Lot Number: 206719/C0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Initial Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention