MAUDE Adverse Event Report: VYGON GMBH LEADERFLEX; INTRAVASCULAR CATHETER

Model Number 1212.08

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Although we did not receive a faulty sample, the customer's description shows that the incident clearly was caused by severe faulty handling against the product's ifu.In the universal cautions no 6.It is outlined that "before the catheter is advanced through the skin, check that there is sufficient length of guidewire exposed to ensure that the guidewire will exit the catheter hub." the user obviously did not follow this advice.We recommend to retrain the user in catheter handling according the product's ifu.

Event Description

During the insertion of a mid line' catheter on the ward, the delivery of antibiotics at home, the guidewire became lost' in the patient's vein and could not be retrieved.

• 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: jillian mikovich ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 6049073
• MDR Text Key: 58129154
• Report Number: 2245270-2016-00067
• 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: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1212.08
• Device Lot Number: 280116GF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 70 YR