MAUDE Adverse Event Report: VYGON GMBH LEADERFLEX; INTRAVASCULAR CATHETER

Catalog Number 1212.08

Device Problem Material Fragmentation (1261)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

The malfunctioning sample was not returned, but a malfunctioning sample of a different length has been 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

Catheter found broken.Patient is ok according to customer contact.

Manufacturer Narrative

This complaint is not confirmed.The complaint and returned sample have been submitted to vygon (b)(4), which is where this part was manufactured, for evaluation.The following is the report of their investigation.An examination of the returned sample shows that the extension line had been torn out of its ll-hub.The proximal end of the extension line has typical signs of a sufficient molding into the hub.Partly rounded edges, marks of the distal end of the hub and the widened end of the tube are typical signs for this finding.The breaking force between ll-hub and extension line should be a minimum of 10n.For the involved batch the range of the tensile force between extension line and ll-hub was between the minimum of 13.59n and the maximum of 31.00n.The batch history did not show any abnormities.This is the first complaint for batch 080714gd and the second for code 1212.08 regarding the described defect within the last 14 years.A manufacturing fault can be excluded for this kind of defect as this is an isolated event.Corrective/preventative action: no further corrective action initiated by quality management.Vygon will continue to monitor this type of complaint in their complaint tracker.

Event Description

Catheter placed on (b)(6), and found broken on (b)(6).Patient is ok according to customer contact.

• 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: 5717046
• MDR Text Key: 47199811
• Report Number: 2245270-2016-00038
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1212.08
• Device Lot Number: 080714GD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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