MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX428T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data the progav¿ 2.0 was manufactured by a qualified employee in february 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav¿ 2.0 has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx428t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received in strong, presumably bloody moldy liquid in the provided returnkit.The condition of the product is rated as the highest risk level.Therefore, a device investigation was not possible due to the return condition.Result: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.However, manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.

Event Description

It was reported miethke that a progav 2.0 sys w/sa25 a.Sprung reservoir (part # fx428t) was implanted during a procedure performed on an unknown date.According to the complainant, a blockage of the valve was suspected.The patient underwent a revision procedure on an unknown date.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR
• 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: 12385809
• MDR Text Key: 268734131
• Report Number: 3004721439-2021-00606
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20029353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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