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 Date 02/02/2018

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

Five days after catheter insertion they realized that the catheter was broken.Patient outcome: catheter fragment was removed surgically.

• 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: 7450779
• MDR Text Key: 106194215
• Report Number: 2245270-2018-00020
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1212.08
• Device Catalogue Number: 1212.08
• Device Lot Number: 150316GF OR 200917GG
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 04/23/2018
• 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