MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SPRUNG RESERVOIR-SET M.DISTALEM KATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FV046T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Head Injury (1879); Hemorrhage/Bleeding (1888); Hydrocephalus (3272)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with fv046t + fx417t shunt system.According to the complainant, the valve was believed to be operating with blockage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Patient information: age: (b)(6) years.Explantation: (b)(6) 2021.The same event: medwatch#3004721439-2021-00134.

Manufacturer Narrative

The same event: medwatch#3004721439-2021-00134.Investigation: visual inspection: no abnormalities were detected during the visual inspection.Permeability test: the test showed that the sprung reservoir is permeable, filled with liquid and pumpable.Results: based on our investigation results, we cannot identify a malfunction of the reservoir.However, we assume that the significant deposits found within the combined progav 2.0 valve (rm 3884 - 400511420) may have temporarily caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the system.We can exclude a defect at the time of release.All products 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.

• Brand Name: SPRUNG RESERVOIR-SET M.DISTALEM KATHETER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11849734
• MDR Text Key: 251451742
• Report Number: 3004721439-2021-00133
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906136598
• UDI-Public: 4041906136598
• Combination Product (y/n): N
• PMA/PMN Number: K110206
• 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: 06/22/2021

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: FV046T
• Device Catalogue Number: FV046T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR