MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/PRECHAMBER 4/19; HYDROCEPHALUS MANAGEMENT

Model Number	FV283T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a paedigav distal catheter ruptured postoperatively.The valve was implanted on (b)(6) 2006.It was revised on (b)(6) 2017 and was returned to the manufacturer.Further details were not provided.Height: 120 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition): the valve with distal catheter was received in a plastic container.Results: first we performed a visual inspection with the valve.The investigation revealed that the valve had no deformations or other abnormalities.Also the catheter showed no abnormalities.Why the cather ruptured is unknown, and it takes an enormous amount of force necessary until the catheter would rupture.We do not have equipment to investigate calcification.The catheter looks like a normal catheter; we assume there is no calcification.However, we can say surely that the ligature thread is not a product from miethke; it is a blue ligature at the catheter connection.Maybe the ligature was not properly attached to the reservoir and thus the detachment occurred.But there could be a variety of reasons and causes of a rupture, which would be dependent upon many different circumstances.An analysis of the reason not possible.The manufacturing of the shunt system and the in process controls guarantee the integrity of the product.All products are 100% performance tested and visually inspected during assembly, packaging, and prior to final packaging.The valve was sterilized by miethke and released for shipment, which was documented as well.No further actions required.

• Brand Name: PAEDIGAV SYSTEM W/PRECHAMBER 4/19
• 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: 13029032
• Report Number: 3004721439-2021-00845
• Device Sequence Number: 4180012
• Product Code: JXG
• UDI-Device Identifier: 04041906115906
• UDI-Public: 4041906115906
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: FV283T
• Device Catalogue Number: FV283T
• Device Lot Number: 20002634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 12/17/2021
• 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: 11 YR
• Patient Sex: Unknown