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

Model Number 1261.203

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

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

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Patient with 5 days of life born at 31 weeks to whom premicath is inserted.After observing difficulty in the insertion and progression of the catheter, the nurse notes that 1.5 cm of the catheter tip is missing and remains lodged in the patient.An x-ray is taken and it is checked that it is placed in the vein.

Manufacturer Narrative

This complaint is not confirmed.We just received the distal 2,3 cm (with tip marking) catheter tube fragment as a sample - obviously the part which surgically had to be removed.Fibrines were adhering to the tube.The proximal part of the catheter had been rejected by the customer.Microscopical examination showed typical signs for a cut and torn catheter tube.A superficial cut on the catheter tube next to the rupture was visible.Therefore we assume that the catheter tube got damaged by the needle bevel during insertion process and could snap at that area when trying to place the catheter in it's correct position.We have a special hint the product's ifu: ""important caution: at no time should the catheter be withdrawn back through a splitting needle.If it becomes impossible to advance the catheter into a satisfactory position, then the needle and catheter must be withdrawn simultaneously.The result of withdrawing a catheter back through the needle can be catheter embolism."" 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.This is the second complaint for batch 040919gm and the third regarding a snapped catheter during placement on code 1261.203.No further corrective action initiated by quality management as there is no hint for a manufacturing fault.".

Event Description

Patient with 5 days of life born at 31 weeks to whom premicath is inserted.After observing difficulty in the insertion and progression of the catheter, the nurse notes that 1.5 cm of the catheter tip is missing and remains lodged in the patient.An x-ray is taken and it is checked that it is placed in the vein.

• 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: 9705708
• MDR Text Key: 179423777
• Report Number: 2245270-2020-00007
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1261.203
• Device Lot Number: 040919GM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention