MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for SPRUNG RESERVOIR SET W/DISTAL CATHETER FV046T manufactured by Christoph Miethke Gmbh & Co. Kg.
[183374328]
Patient height - 170 cm. The reservoir was received in a plastic bag in the original packaging. Visual inspection - in the visual inspection it is investigated if the returned product has defects, deformations or other anomalies. Permeability test - to proof the penetrability of the valves we have carried out penetrability tests. This test is carried out at a hydrostatic pressure of approximately 30 cmh2o in the horizontal direction of flow. Results - first we performed a visual inspection of the reservoir. No significant deformations or damage of the reservoir, but slightly deposits on the membrane are visible. Next, we tested the permeability of the reservoir and the catheters. By pumping and draining liquid it was checked whether the reservoir is permeable. The test result shows that the reservoir has filled with liquid and drained it via the peritoneal catheter. The ventricular catheter is permeable, too. Based on our investigation, we are unable to substantiate the claim of a blockage. The reservoir has drained the fluid and operates within the specified tolerances. We can exclude a defect at the time of release. The sprung reservoir set met all specifications of the final inspection when released from christoph miethke (b)(4). Further actions - no further regulatory actions are required from our point of view.
Patient Sequence No: 1, Text Type: N, H10
[183374329]
It was reported that there was an issue with the shunt system. The patient was initially implanted on an unspecified date. Flow confirmation was implemented by using sprung reservoir and ventricular catheter and by pumping the reservoir. However, the flow was not confirmed. So, the surgeon took off the ventricular catheter and tried to confirm the flow but it did not flow at all. Then, the surgeon cut the edge of the peritoneal catheter and connected it as ventricular catheter but it did not flow. Thus, the cause of the blockage assumed to be the reservoir. The reservoir was not implanted due to the malfunction. Additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00061 |
| MDR Report Key | 9830130 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2018-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-11-26 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOERG KNEBEL |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal | 14469 |
| Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPRUNG RESERVOIR SET W/DISTAL CATHETER |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-13 |
| Model Number | FV046T |
| Catalog Number | FV046T |
| Lot Number | 20044890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Address | 2 ULANENWEG POTSDAM, 14469 GM 14469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |