MAUDE Adverse Event Report: VYGON GMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER,

Catalog Number 1261.307

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

Patient Problem No Information (3190)

Event Date 01/14/2018

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 pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.

Event Description

"the unit manager was removing the premicath when it seems it got stuck and a piece broke off inside the baby".Patient was then taken to the theatre to remove the piece that stayed behind.

Manufacturer Narrative

The sample returned, the intravascular part of the catheter, had a length of 10.5 cm.It was stretched at its proximal end and showed typical signs of tensile elongation.Its proximal end was covered with fibrin tissue.This was obviously the cause for catheter breakage: when the catheter reached the end with fibrin tissue, removal stopped.As the user continued to pull, the catheter stretched and ruptured finally.Having checked the batch history records, no abnormalities were found.In the products ifu we warn:"do not over stretch the catheter as it may rupture, and rebound into the insertion site, causing a catheter embolism.".

Event Description

The unit manager was removing the premicath when it seems it got stuck and a piece broke off inside the baby" patient outcome: patient was then taken to the theatre to remove the piece that stayed behind.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER,
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• MDR Report Key: 7288315
• MDR Text Key: 100648191
• Report Number: 2245270-2018-00008
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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: Health Professional
• Device Catalogue Number: 1261.307
• Device Lot Number: 170816GN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention