MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV434T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/26/2017
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® was manufactured by a qualified employee in july 2013.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 to 20 cmws.The valve specifications after closing the valve for 5 ml/h or 50 ml/h flow for set pressure range 0, 10, 20 cmh2o were fine.The valve was inspected as article fv434t.All parameters (opening pressure, reflux, tightness, adjustability and brake function) have been inspected and signed during the manufacturing process.All parameters have been assessed as meeting specifications.Before release the progav was pre-adjusted to pressure setting 5 cmh2o.Device examination: the progav® was returned submerged in an unidentified liquid.At the time of submission the progav valve was set to pressure range 3 cmh2o.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function was fully operational, however, the braking force has shown a reduced braking force effect.The braking function was given, but less force was needed to release the rotor.Usually a failure of the braking function can be associated with a deformation of the housing membrane, however, no such deformation was initially detected.But in the past, a few cases have occurred in which the housing membrane had a slight convex shape.At the time of submission for investigation the valve had a planar membrane.It is likely that it is nevertheless a slight deformity, maybe caused by a too powerful use of the instruments.This deformation causes a lowering of the membrane.By the set tension of the membrane the braking force is effected.The documented final inspection of the valve, however, confirmed that the product left the company in a perfect condition.Result: first, a visual inspection of the progav® was performed.No significant deformations or damage to the valve were detected.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve was permeable and adjustable.However, the measurement of the braking force has shown a reduced braking force effect.The braking function is given, but less force was needed to release the rotor.Finally, the valve was dismantled.No deposits were observed inside the valve.Against this background, the shunt assistant was investigated.In the course of the optical inspection, no damage was detected.The valve was tested positively for permeability, even if slight residues of deposits could be detected inside the shunt assistant.At the time of the investigation, the claim of occlusion was not able to be substantiated.However, it is possible the very slight deposits inside the shunt assistant could have led to a blockage.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 sys w/sa 20 a.Control reservoir (part # fv434t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was suspected of being occluded approximately two (2) to three (3) months post-implantation.The patient underwent a revision procedure on (b)(6) 2017.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 SYS W/SA 20 A.CONTROL 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: 12836857
• Report Number: 3004721439-2021-00747
• Device Sequence Number: 4950459
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20020699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2013
• 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: Required Intervention
• Patient Sex: Unknown