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

Model Number 1261.307

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Change of the pediatric central venous catheter placed on the child's right arm.When the catheter was removed a proximal rupture was observed.A 1-cm fragment has been found on the chest x-ray at the supra clavicular level.Proximal end of the catheter present at the child's shoulder.Patient outcome: the fragment has not been removed.No migration risk.

Manufacturer Narrative

This complaint is not confirmed.The examination of the faulty sample showed that the catheter snapped 1,7 cm from the distal end (approx.8,3 cm marking).The surface of the separated end was very rough which means that the catheter has not been cut, but has actually been torn off.In a further microscopic examination a leakage was detected at the junction between cannula (distal) and catheter.After removing the cannula, a long rupture with blue suture material could be identified (see pictures).That point also looked constricted.We suppose that the customer fixed the catheter by stitching.Usually this procedure is not used for the catheter-fixation.No deviations of the batch history records detected.Each catheter is flow and leak tested.A 100% visual test is carried out on each catheter.The tensile strength of the catheter tube is tested on a random basis.This is the first complaint received for batch 150218go.There are 5 other complaints available for (b)(4) regarding catheter leakage- but none of them were manufacturing related.We recommend to retrain the users in catheter handling.

Event Description

Change of the pediatric central venous catheter placed on the child's right arm.When the catheter was removed a proximal rupture was observed.A 1-cm fragment has been found on the chest x-ray at the supra clavicular level.Proximal end of the catheter present at the child's shoulder.Patient outcome: the fragment has not been removed.No migration risk.

• 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: 7851273
• MDR Text Key: 119381146
• Report Number: 2245270-2018-00062
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1261.307
• Device Lot Number: 150218GO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention