MAUDE Adverse Event Report: VYGON GMBH LEADERFLEX INTRAVASCULAR CATHETER,

Model Number 1212.08

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The malfunctioning 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 communicated to fda within thirty days of its conclusion via follow-up mdr.

Event Description

A patient received a cvk in the left femoral at (b)(6) hospital, then the patient was transported to an intensive care unit at (b)(6) hospital. At the arrival the patient was circulatory instable, and it was decided that the patient should have an ct-scan. An attempt to place a pvk was made, but they could not place it. When the ct-scan was performed they used the cvk (leaderflex) to give contrast media with a pressure injector, shortly after the cvk stopped to function. When they attempt to change the cvk over the wire the distal end breaks off and the distal end disappears into the vein. Later a surgeon locates the missing part, no complications afterwards are detected. The catheter had been in use for 3. 5 - 4 hours.

• Brand Name: LEADERFLEX
• Type of Device: INTRAVASCULAR CATHETER,
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 7821949
• MDR Text Key: 118405800
• Report Number: 2245270-2018-00055
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K141026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1212.08
• Device Catalogue Number: 1212.08
• Device Lot Number: 200917GG
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/28/2018 Patient Sequence Number: 1