MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG BURRHOLE RESERVOIR SET; HYDROCEPHALUS MANAGEMENT

Model Number FV031T

Device Problem Complete Blockage (1094)

Patient Problem Hydrocephalus (3272)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

Visual inspection: in the first investigation we detected no significant deformations or damage of the reservoir.Permeability test: next, we tested the permeability of the reservoir.By pumping and draining liquid it was checked whether the reservoir is permeable.The test result shows that the reservoir fills with liquid and is emptied again and thus permeable results: on the basis of our investigations we cannot confirm a blockage of the reservoir and the catheters at the time of the investigation.The malfunction complained of cannot be explained to us at the time.We exclude a defect at the time of release.At the time of release by christoph miethke (b)(4) our products meet all specifications of the final inspection.

Event Description

It was reported that there was an issue with a burrehole reservoir set.When the ventricular catheter was set up and pumping was performed on the day, saline did not flow well, and the ligation site was loosened.Again, the same operation was performed after ligation, but it did not flow, so another rented product was replaced with it.Another product with the same material number (b)(4) did not have any problems.No infection.No health damage to the patient.Additional information was not provided.

• Brand Name: BURRHOLE RESERVOIR SET
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: jörg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10087021
• MDR Text Key: 192154095
• Report Number: 3004721439-2020-00091
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV031T
• Device Catalogue Number: FV031T
• Device Lot Number: 20044638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention