MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W. SA20 A.DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FX420T

Device Problems Break (1069); Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem Hydrocephalus (3272)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

The product for investigation has not yet reached us.When additional informations are provided, a follow up will be submitted.

Event Description

It was reported that there was a problem with a catheter the surgeon suspected catheter is broken.The distal catheter from either an fx420t or fx421t fractured spontaneoulsy at the clavicle level 3 years afer implantation.

Manufacturer Narrative

Investigations: visual inspection.The following observations were made during the visual inspection: - catheter ruptured, traces of tears are visible - yellowish discoloration of the catheter permeability test: the test showed that the two parts of the peritoneal catheter are permeable.During the test flushed out some particles.Results: based on our investigation, we are able to substantiate the claim of "fractured catheter".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.We can exclude the possibility of a defect at the time of release.Our peritoneal catheters are tested to 100 % elongation.After the elongation, a constant deformation of 7 % is acceptable.All products met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

Event Description

The product was received for investigation on (b)(6) 2021.Date of implantation: (b)(6) 2017.Date of removal: (b)(6) 2020.

• Brand Name: PROGAV 2.0 W. SA20 A.DISTAL CATHETER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11066690
• MDR Text Key: 223458810
• Report Number: 3004721439-2020-00264
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): Y
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX420T
• Device Catalogue Number: FX420T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR