MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PERITONEALCATHETER 1200MM; HYDROCEPHALUS MANAGEMENT

Model Number	FV072P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and quality control data: the peritoneal catheter was manufactured by a qualified employee on june 2021.Deviations during assembly did not occur.The product was finally tested as article fv072p and released for packaging and sterilization and was sterilized by miethke.All catheter which manufactured by miethke are made of medical silicone.Conclusion information due to the fact that the clinic only requested the ingredients for further testing for possible allergies, the case can only be evaluated as an explantation without malfunction.No malfunction of the catheter was reported and the intolerance of the catheter could not be confirmed.Thus, the reason for explantation remains unclear.Whether it was an allergic reaction, infection, or other possible circumstances has not yet been clarified.However, indications of possible allergic reactions are included in the instructions for use.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that explantation occurred due to a suspicion of allergic reaction to the peritoneal catheter (silicone).The surgeon inquired the manufacturer if there had been any previous cases.It was also inquired about the composition of the silicone catheters so that allergy testing could be performed in the dermatology department.The catheter was implanted for approximately one (1) year and six (6) months without issue.

• Brand Name: PERITONEALCATHETER 1200MM
• 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: 17375177
• Report Number: 3004721439-2023-00204
• Device Sequence Number: 3875180
• Product Code: JXG
• UDI-Device Identifier: 04041906119904
• UDI-Public: 4041906119904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Model Number: FV072P
• Device Catalogue Number: FV072P
• Device Lot Number: 20053497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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 Sex: Unknown