MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG VENT CATHTR W/STYLET & RT-ANG GUIDE PED; HYDROCEPHALUS MANAGEMENT

Model Number FV046P

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, because the product was not received for investigation.A supplemental report was submitted when additional information are provided.

Event Description

It was reported that there was a problem with a ventricular catheter, blockage.Same events were reported as mdr#: 3004721439-2020-00257, 3004721439-2020-00258, 3004721439-2020-0025, 3004721439-2020-00260.Patient information: age: (b)(6) year weight: (b)(6), height: 70 cm, gender: unknown, date of implantation: unknown, date of removal: (b)(6) 2020.

Manufacturer Narrative

Visual inspection in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: additional inserted holes could be detected on one catheter.Permeability test to check if the ventricular catheters are blocked, we have performed a permeability test on the product.The test showed that the ventricular catheter were permeable.Internal inspection of product in order to verify whether the investigated ventricular catheter were 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 catheters.After dismantling of the catheters, was found in one piece of catheter slightly deposits were found.Results: based on our investigation, we are not able to substantiate the claim of "blockage".However, we assume that the significant deposits found within the product may have temporarily 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.We can exclude a defect at the time of release.The product system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

Event Description

The product was received for investigation on 01/04/2021 same events were reported as mdr#3004721439-2020-00257, 3004721439-2020-00258, 3004721439-2020-0059, 3004721439-2020-00260.

• Brand Name: VENT CATHTR W/STYLET & RT-ANG GUIDE PED
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11066574
• MDR Text Key: 223607529
• Report Number: 3004721439-2020-00269
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): Y
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV046P
• Device Catalogue Number: FV046P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 9