MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX597T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Type  malfunction  

Manufacturer Narrative

Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Adjustment test: the progav 2.0 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.Results: based on our inspection results, we cannot identify any functional deviations or other abnormalities in the product.At the time of the investigation, we were unable to determine how the aforementioned adjustment difficulties came about.Especially since we were able to determine that the set opening pressure when the product was returned to us was 0 cmh2o, while the opening pressure on delivery was set to 5 cmh2o.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 regulatory actions are required from our point of view.

Event Description

It was reported that a progav 2.0 shunt system (fx597t) was not adjustable pre-operatively.No patient was involved.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 & PED.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: 18345042
• MDR Text Key: 330840217
• Report Number: 3004721439-2023-00377
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906503543
• UDI-Public: 4041906503543
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX597T
• Device Catalogue Number: FX597T
• Device Lot Number: 20071162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• 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