MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR; HYDROCEPHALUS VALVES

Model Number	FX427T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: optical inspection first step of our investigation is the optical inspection.The optical examination showed that only a very short piece of catheter material was emitted.Permeability test: an adjustment test is not applicable.Adjustment test: an adjustment test is not applicable.Braking force and brake function test: a braking force and brake function test is not applicable.Result: unfortunately, it is not possible to deduce, from the short piece of catheter, why the catheter has detached itself from the reservoir.However, we can say surely that the ligature thread is not product from miethke (b)(4).We use white ligature threads and a black ligature was placed on the catheter we can assume that the catheter with the new ligature was not properly attached to the reservoir and thus the detachment occurred.The manufacturing of the shuntsystem and the in-process controls guarantees the integrity of the product.All products are 100% performance tested and visually inspected during assembling, packaging and before final packaging.The valve was sterilized by miethke and released for shipment and documented as well.A lost catheter, would be detected and rejected from the lot.Accordingly, it is highly unlikely that the product has left our house in the condition you described.Based on our investigation results we could not detect any failure with this shuntsystem at the time of delivery.
Event or Problem Description
It was reported that there was an issue with progav 2.0 sys w/sa20 a.Sprung reservoir (#fx427t).According to the complainant, looseness of ventricular catheter was found.The primary surgery was done in (b)(6) 2017.The looseness was found by x-ray after the patient was discharged from the hospital.According to the x-ray, the catheter was come away approximately 1.5cm from the reserver.The catheter was returned to the manufacturer for evaluation.Further details were not provided.Age: (b)(6).Weight: (b)(6).Height:158cm.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS VALVES
• 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: 12952838
• Report Number: 3004721439-2021-00799
• Device Sequence Number: 17384431
• Product Code: JXG
• UDI-Device Identifier: 04041906136970
• UDI-Public: 4041906136970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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 Expiration Date: 01/10/2022
• Device Model Number: FX427T
• Device Catalogue Number: FX427T
• Device Lot Number: 20032903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• 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: 77 YR
• Patient Sex: Unknown
• Patient Weight: 67 KG