MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX490T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Additional 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 october 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 fx490t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Investigative statement: on the basis of juristic requirements, the surgeon must provide a personal request as a step of safeguard.Unfortunately, no consent was received from the surgeon.An official release is missing for the investigation of the product.For this reason, the product was returned for discharge without examination.Result as described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.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 or Problem Description
It was reported to miethke that a progav 2.0 with ped.Burrhole reservoir (part # fx490t) was to be implanted during a procedure performed on (b)(6) 2017.According to the complainant, the shunt system was not working properly when put together and inline, but each component (reservoir, valve, & shunt assist) seemed to work individually.The surgeon took out the valve system and replaced it with all new components of the same product.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.

• Brand Name: PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR
• Common Device Name: 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: 12795260
• Report Number: 3004721439-2021-00765
• Device Sequence Number: 5271397
• Product Code: JXG
• UDI-Device Identifier: 04041906137786
• UDI-Public: 4041906137786
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: FX490T
• Device Catalogue Number: FX490T
• Device Lot Number: 20032091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Unknown
• Patient Weight: 4 KG