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

Model Number 1261.306

Device Problems Break (1069); Material Fragmentation (1261); Material Split, Cut or Torn (4008)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

The line had been placed in an ex-premature with rsv bronchiolitis (now a terme) and was no longer needed after clinical stabilization.The attempted removal was unsuccessful (obvious resistance when pulling) and eventually the line was torn off and a portion remained in the patient, and had to be surgically removed.

Manufacturer Narrative

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

Manufacturer Narrative

This mdr was initially sent under number 2245270-2023-00004 on feb 07, 2023.This report require a correction.Correction: the product code and lot number associated with the complaint should be 1261.306, lot 290822gqg.The previous report listed (b)(4), lot # 290922gp erroneously.This complaint is not confirmed.(classification according to sop 002).We received the catheter as a sample.Returned sample consists of 4 parts.Fragment 1 is the surgically removed fragment with a length of 11 cm.Fragment 2 has a length of 15.8 cm snapped by mark 26.4 cm, and fragment 3 has a length of approx.4 cm (last part of catheter tube with bold black mark at the proximal end).Fragment 4 is the extension line and the end of the premicath which has been preserved.Here the customer pulled off a piece to test how hard you must pull it before the line breaks.So, this was done after the incident.If the customer wouldn't have tested it fragment 2 and the remaining catheter fragments would be connected.The proximal end of fragment 1 is filled with blood residues.To dissolve the blood residues the catheter fragment 4 was put in warm water.Afterwards the clotted blood in the wing (pink adapter) was removable.The remaining catheter tube protruding from the pink adapter had a length of 1.5 cm.The microscopic examination of all fracture planes showed rough and uneven surfaces, which is a typical sign for a tensile fracture due to a high tensile load.We have made several images (n=18).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.For the involved batch the min value of 1.50 n is requested for the catheter tube and the test reports show values between 4.99 n and 5.98 n with an average value of 5.48 n for the catheter tube.Visual tests and incoming goods inspections are carried out.There are no further complaints for batch 290822gq and eleven further complaints regarding a snapped catheter tube on code 1261.306 within the last three years.No further corrective action was initiated by quality management as there is no hint of a manufacturing fault." no further corrective action was initiated by quality management as there are no indications of a manufacturing fault.".

Event Description

The line had been placed in an ex-premature with rsv bronchiolitis (now a terme) and was no longer needed after clinical stabilization.The attempted removal was unsuccessful (obvious resistance when pulling) and eventually the line was torn off and a portion remained in the patient, and had to be surgically removed.

• 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: 16311305
• MDR Text Key: 309033959
• Report Number: 2245270-2023-00004
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1261.306
• Device Lot Number: 290822GP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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