MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FV441-T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

This complaint was reopened in reference to (b)(4).Investigation: we received the valve in a clear bag.The valve was not inserted in liquid and was sent dry.The progav was set to pressure range 0 cmh2o at the time of delivery.Optical inspection: first step of our investigation is the optical inspection.The visual inspection revealed that the valve has no apparent deformations or other abnormalities.The examination of the parallelism could confirm this as well.The measured value was within the accepted tolerance.Result: first of all we want to point out that we received the valve dry in a plastic bag (without liquid).The investigation of a dry valve is not significant because dry deposits of liquor and blood can affect the product performance.In spite of this, we still decided to investigate the valve.In the visual inspection of the valve, we could not detect any apparent damage.This could be additionally confirmed by measuring the parallelism.To proof if the brake function is full in place we carried out a brake function test.The investigation has shown that the brake function is present.Also the braking force is inside the accepted tolerance.Moreover, it was possible to adjust the valve in all pressure ranges up and down again in the same way.Further we carried out a permeability test.The investigation has shown that the valve was not permeable.Because the valve was sent dry, we suspect that dry deposits inside the valve probably have been affected the product performance.Based on our investigation results, we cannot confirm that it was not possible to adjust the valve.Every adjustment was possible by using the progav check mate.But at the time of delivery there is no failure detectable with this progav valve.No further actions required.

Event Description

According to the complainant a progav had a malfunction postoperatively after four (4) days.The patient was originally implanted on an unspecified date.It was confirmed that adjustment had positively been tested preoperatively.Readjustment was not possible.The event date was (b)(6) 2016.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS PED.W/SA 20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12540365
• MDR Text Key: 273577003
• Report Number: 3004721439-2021-00669
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906130930
• UDI-Public: 4041906130930
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FV441-T
• Device Catalogue Number: FV441-T
• Device Lot Number: 20029316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention