MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG BURRHOLE RESERVOIR WITH DISTAL CATHETER; HYDROCEPHALAUS MANAGEMENT

Model Number FV027T

Device Problems Break (1069); Mechanical Problem (1384); Material Rupture (1546); Material Integrity Problem (2978)

Patient Problem Hydrocephalus (3272)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a burr hole reservoir w/catheter (part # fv027t) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the operation, while the surgeon attempted to attach to shunt, a lack of heat seal was noted on end of catheter to reservoir.Surgeon was then going to reattach catheter, but found the inlet was loose.The procedure was then continued and successfully completed using another of the same type of device.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.

Manufacturer Narrative

Investigation: visual inspection: the following observations were made during the visual inspection: ruptured catheter.Reservoir inlet with visible part of the ruptured catheter.Results: based on our investigation results, we can identify a ruptured catheter.At the time of the investigation, it was not clear to us how the mentioned rupture occurred.We cannot explain the cause of this type of failure and would like to remind that the catheter should not be in contact with sharp objects during the surgery, also should be avoided too strong pulling the catheter.This type of catheter/reservoir connection was abolished some time ago and changed to a connection with ligature.Thus, a reconnection of separate components is possible at all times.We can exclude a defect at the time of release.The reservoir met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: BURRHOLE RESERVOIR WITH DISTAL CATHETER
• Type of Device: HYDROCEPHALAUS 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: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12711851
• MDR Text Key: 278805856
• Report Number: 3004721439-2021-00289
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906116804
• UDI-Public: 4041906116804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: FV027T
• Device Catalogue Number: FV027T
• Device Lot Number: 20032915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1