MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX440T

Device Problems Mechanical Problem (1384); Increase in Pressure (1491)

Patient Problem Hydrocephalus (3272)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was a problem with a progav 2.0.The patient was implanted with the shunt, the product failed to regulate pressure and the patient developed symptoms of high intracranial pressure.After two months the doctor removed the shunt and reimplanted a new product.Patient information: age: (b)(6) years.Weight: (b)(6).Hight: 178 cm.Gender: unknown.Implantation: (b)(6) 2020.Explantation: (b)(6) 2020.

Manufacturer Narrative

New information are provided with returned product.The serial number indicated a different delivery lot as the previous one.Additional data about the patient were transmitted.These have been updated in this follow up report.D4 model: fx440t.D10 device returned by manufacturer 08/04/2020.G5 pma/510(k) number: k161853.In addition, the product has now been finally investigated.Investigation results: visual inspection: no deviations are detected.Permeability test: the test showed that the progav 2.0 is permeable.Computer controlled test: the test has shown the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/hr in a horizontal position, to be 1.39 cmh2o.This is not within the specified tolerance of 7 cmh2o ± 3 cmh2o.An applied pressure of 1.39 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 7 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can observe a presence of an over- drainage.Adjustability test: the progav 2.0 was found to be found to be non-adjustable within the specified range.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present due to the non-adjustability of the valve, an investigation of the braking force was not possible.Internal inspection of product: after dismantling of the valve, clearly deposits were found in progav 2.0.Results: based on our investigation, we are not able to substantiate the claim of "under-drainage" but we confirm the presence of "non-adjustability" and "over- drainage".We are assuming that the deposits detected within the valve have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, 14469 ; GM 14469
• MDR Report Key: 10373032
• MDR Text Key: 202006717
• Report Number: 3004721439-2020-00149
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: FX440T
• Device Catalogue Number: FX440T
• Device Lot Number: 20037830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 70