MAUDE Adverse Event Report: VYGONGMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.306

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

Although the malfunctioning device is not available for evaluation, the results of this investigation will be communicated to the fda through a follow-up mdr upon its completion.

Event Description

Catheter was to be removed, it tore off at 15cm, and the rest was retrieved by catheter intervention.The catheter was inserted in the right elbow via a yellow pvc.Length 30cm, i.E.Fully advanced after measurement.After placement, x-ray position check with correct position: end projected onto superior vena cava.The catheter was fixed in place with intravenous lying pvc (yellow pvc) using sterile plasters and foil plasters.Behavior during removal: "usual resistance" during removal was described, no extreme "stretching" of the catheter.On removal, it was noted that the catheter was incompletely removed and x-rayed for visualization.Further information from the customer: no problems at all on insertion, even when removing the stylet.Infusions: nacl+glucose 5%, jonosteril, cefotaxime-lsg, and vancomycin-lsg as short infusions.Infusion rates between 5 and 50ml/h; period of use: (b)(6) 2023 ca.6 pm until (b)(6) 2023 ca.11 pm.

Event Description

Catheter was to be removed, it tore off at 15cm, and the rest was retrieved by catheter intervention.The catheter was inserted in the right elbow via a yellow pvc.Length 30cm, i.E.Fully advanced after measurement.After placement, x-ray position check with correct position: end projected onto superior vena cava.The catheter was fixed in place with intravenous lying pvc (yellow pvc) using sterile plasters and foil plasters.Behavior during removal: "usual resistance" during removal was described, no extreme "stretching" of the catheter.On removal, it was noted that the catheter was incompletely removed and x-rayed for visualization.Further information from the customer: no problems at all on insertion, even when removing the stylet.Infusions: nacl+glucose 5%, jonosteril, cefotaxime-lsg, and vancomycin-lsg as short infusions.Infusion rates between 5 and 50ml/h; period of use: (b)(6) 2023 ca.6 pm until (b)(6) 2023 ca.11 pm.

Manufacturer Narrative

This complaint is not confirmed.(classification according to sop 002).Even if no faulty sample was available and no investigation of the sample could be performed, the fact that the catheter was used on a child weighing 22.8 kg, point out that obviously the wrong choice of catheter was done.According to the complaint form, we got following information: " catheter was to be removed after 4 days, it snapped at 15cm, the rest was retrieved by catheter intervention.Insertion: catheter was inserted in the right antecubital fossa via a yellow pvc.Length 30cm, i.E.Fully advanced after measurement.After placement, x-ray position check with correct position: end projected onto superior vena cava.Patient born in 2015, weighing 22.8 kg, chronically ill catheter was fixed in place with intravenous lying pvc (yellow pvc) using sterile plasters and foil plasters.Behaviour during removal: "normal resistance" during removal was described, no extreme "stretching" of the catheter.On removal, it was noted that the catheter was incompletely removed and x-rayed for visualisation.Further information from the customer: no problems at all on insertion, even when removing the stylet.Infusions: nacl+glucose 5%, jonosteril, cefotaxime-lsg and vancomycin-lsg as short infusions.Infusion rates between 5 and 50ml/h." since we received whether the faulty sample nor an image showing the defect, no investigation is possible.However, a 1 fr premicath catheter was used for premature and newborn babies with a birth weight of less than 1000 g in an 8-year-old child weighing 22.8 kg.A child > 1000 g is considerably more agile than a child < 1000 g, especially an 8-year-old child weighing 22.8 kg.Such a child can also exert much higher forces and a delicate catheter tube like that of the premicath can tear much easier.Since no batch number was available, checking of the batch history records whether deviations occurred was not possible.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked.The min.Value of 1.5 n is requested regarding the tensile force for the catheter tube.For the involved code (b)(4), checking if the batch is within our specification is not possible, because the batch is unknown.Incoming goods inspections and two 100% visual tests after packaging are carried out.It is not possible to query the database for the batch, as no batch has been transmitted by the customer.There are nine further complaints regarding a snapped catheter tube on code 1261.306 within the last three years.This query relates to all complaints that have come to our attention worldwide.No action is taken as the catheter could not meet the requirements for this patient.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 18422574
• MDR Text Key: 331682254
• Report Number: 2245270-2023-00086
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1261.306
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 23 KG