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

Model Number 1261.208

Device Problems Fluid/Blood Leak (1250); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2022

Event Type  Injury  

Event Description

Device site noted to be leaking.Dressing removed in order to observe site more closely and noted to require removal due to issue with leakage.When line inspected the full line was not removed and part of the device was noted to still be in the patient.Radiological investigations have confirmed the line is still insitu within the patients body.Remedial action: reviewed by cardiology team and will require surgical removal of line.Remainder of line has been retained for inspection.Additional information: fully aware of what has happened and that removal of line is not possible.Section of catheter not removed and retained in the patient.".

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.

Event Description

Device site noted to be leaking.Dressing removed in order to observe site more closely and noted to require removal due to issue with leakage.When line inspected the full line was not removed and part of the device was noted to still be in the patient.Radiological investigations have confirmed the line is still insitu within the patients body.Remedial action: reviewed by cardiology team and will require surgical removal of line.Remainder of line has been retained for inspection.Additional information: fully aware of what has happened and that removal of line is not possible.Section of catheter not removed and retained in the patient.".

Manufacturer Narrative

This complaint is not confirmed.(classification according to sop 002).We received one catheter as a sample.The faulty sample snapped close to the 15cm marking.The distal fragment is missing.The proximal fragment is flushable and tight.A microscopic examination demonstrated that the fractured plane showed a rough and uneven surface, which is a typical sign for a tensile fracture due to a high tensile load.Having checked the batch history records, no deviations were found.The batch complied to its specification and was released.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.The min value of 1.5 n is requested regarding the tensile force of the catheter tube.For the involved code 6g35961012, batch 8145356 had a mean of 5.40 n (range between 5.04 n and 5.73 n) and is therefore within the specification.Visual tests and incoming goods inspections are carried out.From previous complaints we know different causes of a leakages at the described area which often results in a tensile fracture: dressing change - in some instances the catheter can become adhered to the dressing and additional pulling is required to free it, placing stress on the line resulting in a tensile fracture.Routine care - when lifting the baby to change bedding.Movement - the baby themselves catching the line, normally with a foot, during movement.We don't know if the customer used alcohol-based chlorhexidine as a disinfectant.But we have a special hint in the products ifu: "be aware that organic solvents such as alcohol or acetone may interact with catheter material and weaken it." and "avoid any contact of the catheter tubing to alcohol containing disinfectants.This may irreversibly damage the catheter." moreover, we have a warning on the label and a separate warning leaflet in each blister concerning this matter.In addition to the poor properties of alcohol on the catheter material, any tensile stress or contact with sharp-edged instruments should be avoided.Because of several tests done during production we can exclude a manufacturing related fault.This error type is not known internally.We only know this from customer complaints after the catheters have been used improperly.There are three further complaints for batch 150322gs and one further complaint regarding leaking and later snapped catheter on code 1261.208 within the last three years.No further corrective action was initiated by quality management as there are no indications of a manufacturing fault.

• 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: 15632981
• MDR Text Key: 302010059
• Report Number: 2245270-2022-00103
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K954302
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1261.208
• Device Lot Number: 150322GS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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