MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 20; HYDROCEPHALUS VALVES

Model Number FX413T

Device Problems Mechanical Jam (2983); Overcorrection (3006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Date of event: unknown.Date of implant: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "valve unadjustable was implanted, operated on to remove and customer stated valve is jammed.".

Manufacturer Narrative

Investigation: visual inspection: scratches and bloody residue on the outer housing of the valve was observed through the visual inspection.No significant deformations or damages were detected.Permeability test: a permeability test has shown that the progav 2.0 valve is permeable.Adjustment test: the progav 2.0 valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: we have dismantled the valve.We found deposits of substances (likely protein) both inside the valve and on the inside of the top of the valve.Based on our investigation, we are unable to substantiate the claim of non-adjustability.The valve operates within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 20
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7834439
• MDR Text Key: 118813021
• Report Number: 3004721439-2018-00210
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: FX413T
• Device Catalogue Number: FX413T
• Device Lot Number: 20031602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Distributor Facility Aware Date: 11/09/2018
• Device Age: 2 YR
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR