MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number	FV250T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample not received for investigation.When following informations /investigations results are provided a follow up will be submitted.
Event or Problem Description
It was reported that there was a problem with a shunt assistant.Tha valve was used with another devices for hc therapy.The products were used on the lp shunt on (b)(6) 2020.They were removed on (b)(6) 2021 due to the symptoms of under- drainage.Please investigate the inside of the valve.Patient informations: age: (b)(6) years.Implantation: (b)(6) 2020.Revision: (b)(6) 2021."associated medwatches: 3004721439-2021-00019, 3004721439-2021-00021, 3004721439-2021-00022 mdr # - same patient".
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -the inlet catheter was not produced by christoph miethke gmbh & co kg.-the shuntassistant was connected to the third-party catheter and a connector (#3004721439-2021-00021) permeability test: the test showed that the shuntassistant is permeable.Computer control test: the computer controlled test has shown the opening pressure of the shuntassistant, at a reference flow rate of 20 ml/h in a vertical position, to be 15.32 cmh2o.This is within the specified tolerance of 15 cmh2o +4/-2 cmh2o.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.After dismantling of the valve, no deposits were found in shuntassistant.Results: based on our investigation, we are not able to substantiate the claim of "blockage".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.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.From our point of view, no further regulatory actions are required.
Event or Problem Description
"associated medwatches: 3004721439-2021-00019, 3004721439-2021-00021, 3004721439-2021-00022 mdr # - same patient".

• Brand Name: SHUNTASSISTANT 15
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11334203
• Report Number: 3004721439-2021-00020
• Device Sequence Number: 11024419
• Product Code: JXG
• UDI-Device Identifier: 04041906113100
• UDI-Public: 4041906113100
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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 Expiration Date: 03/25/2025
• Device Model Number: FV250T
• Device Catalogue Number: FV250T
• Device Lot Number: 20046947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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
• Patient Age: 70 YR