MAUDE Adverse Event Report: PROGAV 2.0 SYSTEM WITH SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX424T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition): the valve was received dry in the provided returnkit (not submersed in liquid as suggested).Result: it should be noted that the valve was received dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the progav.Besides scratches, no significant deformations wer detected.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve was permeable, albeit difficult, and bloody fluid was flushed out.The valve could be adjusted to all specified pressures and the brake function as well as the brake force could be measured as expected.Finally, we have dismantled the valve.Inside the valve we have found a small amount of build-up substances (likely protein).Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the valve was shown to be permeable, albeit with difficulty.However it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further actions required.
Event or Problem Description
According to the complainant a progav was blocked postoperatively.The patient was originally implanted on (b)(6) 2017; 18 days later, the malfunction was noted.The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV 2.0 SYSTEM WITH SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12752517
• Report Number: 3004721439-2021-00708
• Device Sequence Number: 1507830
• Product Code: JXG
• UDI-Device Identifier: 04041906136949
• UDI-Public: 4041906136949
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FX424T
• Device Catalogue Number: FX424T
• Device Lot Number: 20029765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Weight: 6