MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 20 & DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX648T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx648t) was implanted during a procedure performed in 2020.According to the complainant, the peritoneal catheter was found to be torn abdominally (the catheter was identified as part of fx648t).The patient underwent a revision procedure on (b)(6) 2022.The complaint device has not yet been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 9 years.Gender: female.
Additional Manufacturer Narrative
Investigation: the catheter returned for investigation.Visual inspection: splitted/ broken catheter with cut marks were detected during the visual inspection.Verification of catheter rupture: for verification, a tensile test was performed to one of the intact returned catheter pieces.The tensile force was increased step by step until the catheter finally ruptured.As a result, the tearing edge was examined, compared with the tearing edge sent in and documented.Results: based on our comparative examination results, we have to assume that the returned catheter must have been pre-damaged.Otherwise, a different tearing edge would be visible.The catheter has a completely different " tearing edge", so that an explicit tearing cannot be present.Due to the growth of the child (implantation time: 2 years, child age: 9 years - still growing), a possibly pre-damaged catheter can be ruptured.It is not possible to retrospectively determine how the presumed damage to the catheter occurred.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & DISTAL CATHETER
• 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: 14633055
• Report Number: 3004721439-2022-00160
• Device Sequence Number: 5918243
• Product Code: JXG
• UDI-Device Identifier: 04041906502065
• UDI-Public: 4041906502065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 05/17/2025
• Device Model Number: FX648T
• Device Catalogue Number: FX648T
• Device Lot Number: 20047879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2020
• 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: 9 YR
• Patient Sex: Female