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

Model Number 1261.306

Device Problems Break (1069); Material Fragmentation (1261); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will be returned to vggon for 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 via follow-up mdr.

Event Description

When trying to withdraw the catheter after 8 days insitu catheter tube snapped at 22 cm; surgical remove of remaining catheter fragment necessary.

Manufacturer Narrative

This complaint is not confirmed.We received a catheter as a sample which still stuck inside the cannula and had snapped distal at approx.6,8 cm.The distal catheter fragment had not been returned.The catheter could be flushed and did not show a leakage.The catheter had been elongated between distal snapped point and the 10 cm marking.Microscopic examination showed that the distal tip of the catheter was enlarged.Further the opening of the catheter tube had an oval shape and showed a rough surface - typical for a breakage due to an overload of tensile force.The catheter obviously had been elongated before snapping.As we did not receive the batch no.We could not look to the batch history.In addition to a 100% flow and leak test the tensile force of the catheter tube is tested randomly.This is the 18th complaint regarding a snapped catheter tube on code 1261.306 within the last three years.Without the catheter fragment and the batch no.No further analysis is possible.As the catheter worked well for 8 days a manufacturing fault is very unlikely.

Event Description

When trying to withdraw the catheter after 8 days insitu catheter tube snapped at 22 cm; surgical remove of remaining catheter fragment necessary.

• 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: 7450507
• MDR Text Key: 106156996
• Report Number: 2245270-2018-00018
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1261.306
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention