MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA10 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMNET

Model Number FX432T

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Manufacturing and quality control data: we have only received the product data without serial number.The product itself is not available for an investigation.Without a serial number it is not possible for us to retrace the complained product.Nevertheless, we can ensure that the progav 2.0 shunt system has a normal pressure range of 0 to 20 cmh2o.All parameters (opening pressure, reflux, tightness, adjustability and brake function) are inspected and signed during the manufacturing process.The progav 2.0 shunt system was manufactured by a qualified employee in may 2018.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav 2.0 shunt system is comprised of a progav 2.0 adjustable valve and a shuntassistant fixed pressure valve.The progav 2.0 valve has a normal pressure range of 0 to 20 cmh2o.The shuntassistant has a fixed pressure of 10 cmh2o.Before release, the progav 2.0 was pre-adjusted to a pressure setting of 5 cmh2o.Result: an investigation was not possible because no product was send for investigation.Without a detailed investigation, a meaningful analysis of the cause of the mentioned catheter disconnection is not possible.However, we can ensure that all our products are released for shipment only in a perfect condition due to a documented final check.All products of the delivery note met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further actions are required from our point of view.

Event Description

It was reported that a progav 2.0 shuntsystem (#fx432t) was implanted during a procedure performed on (b)(6) 2018.According to the complainant, the posterior catheter was disconnected.The patient returned sometime later and complained that she was "not feeling right".A shunt series was ordered and results showed that the distal catheter was fractured.When the surgeon examined the patient in the operating room, the shunt was exposed and the posterior catheter was noted to be completely disconnected (below the reinforced section distal to sa).After finding the distal break, the system including reservoir, progav, and shunt assistant was explanted.Another miethke product, fx817t was implanted instead.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.No further patient infromation are available.

• Brand Name: PROGAV 2.0 SYS W/SA10 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS MANAGEMNET
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12509623
• MDR Text Key: 272588768
• Report Number: 2916714-2021-00186
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137304
• UDI-Public: 4041906137304
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: FX432T
• Device Catalogue Number: FX432T
• Device Lot Number: 20037951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Distributor Facility Aware Date: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention