MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PRECHAMBER PED.; HYDROCHEPHALUS MANAGEMENT

Model Number	FV035T
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem Description
The complainant reported that a progav 2.0 with shunt assistance 20 (part # fx413t) (ref.Associated mdr id 3004721439-2020-00182) and prechamber (part # fv035t) were implanted in a patient on (b)(6) 2019.Reportedly, contrast medium was injected into the device, which revealed that the flow was blocked at the location of the shunt valve.The patient underwent revision surgery on (b)(6) 2020.No known patient complications.No further additional information is currently available.Associated medwatch: 3004721439-2020-00182.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: significant deposits are visible within the reservoir.Permeability test: the test did not show any flow, because the deposits placed in front of the outlet spout and blocked the prechamber, thus preventing drainage.Results: based on our investigation, we are able to substantiate the claim of "blockage".We are assuming that the deposits detected within the prechmaber have 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.From our point of view, no further regulatory actions are required.Same patient medwatch: #3004721439-2020-00182.

• Brand Name: PRECHAMBER PED.
• Common Device Name: HYDROCHEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10546417
• Report Number: 3004721439-2020-00183
• Device Sequence Number: 14256998
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 09/23/2020

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 Model Number: FV035T
• Device Catalogue Number: FV035T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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