MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM MIT CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX431T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 system with control reservoir (part # fx431t) and a shuntassistant 15 (part # fv250t) (ref.Mdr id 3004721439-2021-00136) were implanted during a procedure performed on an unknown date.According to the complainant, the valve was believed to be have a blockage.The patient underwent a revision procedure on (b)(6) 2021.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Although requested, additional information has not been made available.Explantation: (b)(6) 2021 the same event: medwatch # 3004721439-2021-00136.
Additional Manufacturer Narrative
Investigation: description of product upon receipt: the valve was received together with rm 3885_1 (#med watch 3004721439-2021-00136).Submersed in an unidentified liquid in the provided returnkit.The following products were submitted for return: - progav 2.0 with control reservoir.- peritoneal catheter.- shuntassistant (rm 3885_1 - #med watch 3004721439-2021-00136).Visual inspection: the following observations were made during the visual inspection: - clearly particles in the delivery liquid and some deposits within the reservoir; - particles in the delivery liquid - deposits within the reservoir.Permeability test: the test showed that the progav 2.0 with control reservoir is permeable.Blood and some particles were flushed out during the test.Computer control test: to check the flow rate of the valve, the valve was tested on a miethke computer controlled testing apparatus and passed the standard test.The computer controlled test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 1.03 cmh2o.This is within the specified tolerance of 2 cmh2o ± 3 cmh2o.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product: after dismantling of the valve, no visible deposits were found in the progav 2.0.Results: based on our investigation results, we cannot identify a malfunction in the valve.At the time of the investigation, it was not clear to us how the mentioned functional impairment occurred.No functional deviations were detected.Even small amounts of non-visible deposits/proteins might compromise the integrity of the valve.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.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.
Event or Problem Description
Additional information: height: 177 cm, weight: (b)(6).The same event: medwatch#3004721439-2021-00136.

• Brand Name: PROGAV 2.0 SYSTEM MIT CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11848753
• Report Number: 3004721439-2021-00135
• Device Sequence Number: 3792226
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2025
• Device Model Number: FX431T
• Device Catalogue Number: FX431T
• Device Lot Number: 20048607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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 Weight: 62