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

Model Number 1261.20

Device Problems Material Fragmentation (1261); Migration (4003); Material Split, Cut or Torn (4008)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion.

Event Description

"during placement the catheter got cut when removing the needle.Approximately 11 cm remained inside the vessel.Two x-rays were taken which showed that the catheter fragment had migrated within a time period - finally at the level of vii rib.At the moment it is unknown if the catheter fragment still is inside the patient or could be successfully removed.We do not know the patients condition at the moment.".

Manufacturer Narrative

This complaint is not confirmed.The child died 21 days after the second catheter placement with catheter rupture.But as the customer said the catheter did not affect the outcome.The child has died because of the underlying disease.We just received the proximal part of the catheter as a sample.The catheter tube snapped within the 12 cm marking.The distal part was still in the died patient.Microscopical examination of the breakage area showed a quite smooth surface which is typical for a mechanical damage.Two radial damages/scratches caused by a sharp instrument (needle?) and a step formation were visible at the catheter tip.The surface within these steps is smooth as well.This catheter obviously was partly damaged due to mechanical force / sharp instrument and then obviously snapped when tensile force had been applied.It might be possible that this catheter tube got damaged due to a bad handling of the peelable needle.The catheter was occluded (dried blood was visible in the catheter tip) and therefore impossible to flush.A slight fibrin formation was visible at the outside.In the product's ifu we have following warnings: "important caution: at no time should the catheter be withdrawn back through a splitting needle.If it becomes impossible to advance the catheter into a satisfactory position, then the needle and catheter must be withdrawn simultaneously.The result of withdrawing a catheter back through the needle can be catheter embolism." and "caution: do not over stretch the catheter as it may rupture, causing a catheter embolism.The catheter is not suitable for blood aspiration." the customer obviously disregards these warnings.Having checked the batch history records, no deviations were found.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out.The tensile force of the involved catheter tube batch was corresponded to our specification.This is the second complaint for batch: 140918gj and the very first regarding a snapped catheter during removal of the needle on code 1261.20 within the last three years.No further corrective action initiated by quality management as there is no hint for a manufacturing fault.".

Event Description

"during placement the catheter got cut when removing the needle.Approximately 11 cm remained inside the vessel.Two x-rays were taken which showed that the catheter fragment had migrated within a time period finally at the level of vii rib.At the moment it is unknown if the catheter fragment still is inside the patient or could be successfully removed.We do not know the patients condition at the moment.".

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• MDR Report Key: 10047683
• MDR Text Key: 190698451
• Report Number: 2245270-2020-00025
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K954302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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
• Device Operator: No Information
• Device Model Number: 1261.20
• Device Lot Number: 140918GJ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention