MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W.SA 20 A.BURRHOLERES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV448T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on our investigation results, we can determine visible cutting and crack marks.The cut marks indicate a damage by a sharp instrument.The tearing (visible traces) could possibly have been caused by the movement of the head, because the shunt system was placed in a non-optimal area in the neck (soft tissue).In addition, the growth of the child may have also contributed to the rupture of the catheter.
Event or Problem Description
It was reported that a progav shuntsystem (#fv448t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the abdominal catheter is ruptured behind the shunt.The catheter was removed and a new catheter was connected and implanted.The shunt system is still implanted.A part of the complained catheter was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 3 years, 9 months.Height: 103.5 cm.Weight: 16 kg.Gender: male.

• Brand Name: PROGAV SYS PED.W.SA 20 A.BURRHOLERES.
• Common Device Name: 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: 18762663
• Report Number: 3004721439-2024-00036
• Device Sequence Number: 19978301
• Product Code: JXG
• UDI-Device Identifier: 04041906132682
• UDI-Public: 4041906132682
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FV448T
• Device Catalogue Number: FV448T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 16 KG