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

Model Number FV434-T

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hydrocephalus (3272)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information/ investigation result will be submitted in a supplemental report.

Event Description

It was reported miethke that a progav sys w/sa 20 a.Control reservoir (part # fv434-t) was used during a procedure performed on an unknown date.According to the complainant, when about to place shunt (a progav shuntsystem (fv434-t)), it was found that there was leakage at the edge of reservoir (not at connection).The product was not able to use.Replaced with another one.No patient data available.

Manufacturer Narrative

Investigation: visual inspection: the following observations were made during the visual inspection: -no abnormalities (no visible leakage).Permeability test: the test showed that the progav shunt system is permeable.During the test no liquid drained out in an unintended manner.A leakage was not visible.Internal inspection of product: the kink protection was removed for further investigation of the leakage.After removing the kink protection, a leakage under the ligature was visible.Results: based on our investigation results, we can identify a small leakage in the catheter.A possible cause of the leakage could be an excessive pulling and kinking of the catheter during the implantation.As described in the ifu, avoid this during the implantation.At the time of the investigation, it was not clear to us how the mentioned functional impairment occurred.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

Event Description

It was reported that a progav 2.0 shuntsystem with a control reservoir (#fv434-t) should be implanted on (b)(6) 2021.According to the complainant,a leakage at the edge of reservoir (not at connection) was detected and the shunt was not able to use.Replaced with another one and the surgery finished succesful.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the procedure.Age: 56 years.Height: 175 cm.Weight: 70 kg.Gender: unknown.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12438653
• MDR Text Key: 270292879
• Report Number: 3004721439-2021-00248
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906130862
• UDI-Public: 4041906130862
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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
• Device Operator: Health Professional
• Device Model Number: FV434-T
• Device Catalogue Number: FV434-T
• Device Lot Number: 20045666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70