MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV413T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav has a normal pressure range of 0-10 cmh2o.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Statement: unfortunately we did not receive a consent form signed by the surgeon.An official release is missing, and for this reason we returned the product without examination.Result: 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.No further actions required.
Event or Problem Description
According to the complainant a progav had a malfunction postoperatively.The patient was originally implanted on an unknown date.It was reported that the patient was "getting worse" and the staff tried to unsuccessfully adjust the valve.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV WITH SHUNTASSISTANT 20
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12377905
• Report Number: 3004721439-2021-00601
• Device Sequence Number: 17124576
• Product Code: JXG
• UDI-Device Identifier: 04041906140007
• UDI-Public: 4041906140007
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FV413T
• Device Catalogue Number: FV413T
• Device Lot Number: 20024017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention