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

Model Number FV035T

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.

Event 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.

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.
• Type of Device: HYDROCHEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10546417
• MDR Text Key: 207333384
• Report Number: 3004721439-2020-00183
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• Combination Product (y/n): N
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV035T
• Device Catalogue Number: FV035T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention