MAUDE Adverse Event Report: VYGON GMBH LEADERFLEX 22G 20CM; INTRAVASCULAR CATHETER

Model Number 1212.20

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

One failed sample and several unopened samples from the same lot have been returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of completion.There were 5 occurrences of this issue, the details for the events can be found in the following reports: 2245270-2020-00013, 2245270-2020-00014, 2245270-2020-00016, 2245270-2020-00017.

Event Description

At least 5 20cm leaderflex catheters being used as piccs have broken at various points of usage, from insertion, during dwell, to removal.No harm to patients reported.

Event Description

At least 5 20cm leaderflex catheters being used as piccs have broken at various points of usage, from insertion, during dwell, to removal.No harm to patients reported.

Manufacturer Narrative

The returned samples were evaluated as part of the complaint investigation.The results of this investigation are as follows: there were 5 occurrences of this issue, the details for the events can be found in the following reports: 2245270-2020-00013, 2245270-2020-00014, 2245270-2020-00015, 2245270-2020-00016, and 2245270-2020-00017.Vygon received one used and snapped catheter as a sample, 12 sterile products on code 1212.20 and one sterile sample of the involved guidewire.The catheter tube was confirmed to have snapped approx.3 mm distal the wing.Vygon did not receive the distal fractured catheter tube, only the proximal portion.Microscopic examination of the fractured plane showed the typical rough surface for a tensile fracture.Furthermore, a tear just at the junction from catheter tube to wing was visible, which was assumed to be the result of excessive pulling forces and/or alcohol-based disinfectant.The customer reported that they used a guidewire from nitrex, whose dimensions differ from vygon guidewires.The customer states they were not using vygon guide wire because they do an over the wire technique for placement and our wire is too short.Length: nitrex- 80cm, vygon 50cm.Diameter: nitrex - 0.44cm (0.46cm declared on packaging), vygon - 0.45cm.The nitrex guidewire is also more rigid than vygon guidewires, and is similar to those for lifecath ct picc easy, which have soft tips with an outer spiral and then transition to a rigid wire without a spiral.Vygon also checked the batch history records, and no deviations were found.Each catheter is flow and leak tested during production and the tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out.The tensile force of the involved catheter components was according to our specifications.This is the very first complaint for batch 290519gh and the fifth regarding a snapped catheter tube on code 1212.20 within the last three years.No further corrective action is initiated by quality management as there is no indication of a manufacturing root cause.In addition, vygon recommends stop using the nitrex guidewire since the compatibility was not verified with the vygon catheter.

• Brand Name: LEADERFLEX 22G 20CM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• MDR Report Key: 9866533
• MDR Text Key: 186731731
• Report Number: 2245270-2020-00015
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1212.20
• Device Catalogue Number: 1212.20
• Device Lot Number: 290519GH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1