MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/11/2017
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 necessary.Adjustment test: an adjustment test is not necessary.Braking force and brake function test: a braking force and brake function test is not necessary.Result: unfortunately, it is not possible to deduce, from the short piece of catheter, why and at which point the catheter is torn off.However, we can confirm that an enormous effort is required to cause a cut at the catheter.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 cut, if present, 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.We suspect that the cut was caused by an external force.Based on our investigation results we could not detect any failure with this valve at the time of delivery.
Event or Problem Description
It was reported that there was an issue with fx434t - progav 2.0 sys w/sa20 a.Control reserv.According to the complainant, when the customer pulled the catheter to pass it from head side to abdominal cavity, catheter was broken off.The catheter was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12627430
• Report Number: 3004721439-2021-00691
• Device Sequence Number: 4290842
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: 4041906137328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 06/30/2021
• Device Model Number: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20031563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR