MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX466T

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Hydrocephalus (3272)

Event Date 12/27/2022

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 progav 2.0 with ped.Prechamber (part # fx466t) was to be used during a shunt implant procedure performed on (b)(6) 2022.According to the complainant, the catheter was loose and separating from the reservoir.The issue was noted when the device was removed from the box.No surgical delay or patient impact occurred as a result of the event.

Manufacturer Narrative

Investigation: visual inspection: the following observations were made during the visual inspection: bloody residues on the ligature.Scratches on the pediatric prechamber.Kink protection shifted.A tensile test was performed.No abnormalities were detected during the test.The spout and the catheter are fixed in place.Results: based on our investigation results, we can detect a displacement at the kink protection.However, the shift has no impact on the function of the device.We can exclude a defect at the time of release.The product met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 WITH PED.PRECHAMBER
• 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: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 16258304
• MDR Text Key: 309014976
• Report Number: 3004721439-2023-00001
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137502
• UDI-Public: 4041906137502
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161853
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX466T
• Device Catalogue Number: FX466T
• Device Lot Number: 20061571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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