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

Model Number 1261.20

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Pleural Effusion (2010)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will be returned to vggon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion via follow-up mdr.

Event Description

Deteriotion of respiration and hemodynamics, suspicion of malplaced catheter.Therefore, the idea of pleural drainage was born.

Manufacturer Narrative

It was not possible to flush the catheter because of several occlusions.A thoroughly microscopic step by step examination showed a lot of fibrins adhering to the catheter tube but no defect could be detected which might have led to a leakage.This is the second complaint for batch 040817gj (co-2018-0307 - same customer), the 35th complaint for a leaking catheter tube on code 1261.20 and the 5th regarding inflammation or phlebitis with code 1261.210 within the last 3 years but none of these complaints manufacturing related.This is the first complaint on code 1261.20 regarding oedema within the last 4 years.

Event Description

Deteriotion of respiration and hemodynamics, suspicion of malplaced catheter.Therefore, the idea of pleural drainage was born.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM 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: 7450421
• MDR Text Key: 106155263
• Report Number: 2245270-2018-00015
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K954302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

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: 1261.20
• Device Lot Number: 040817GJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/27/2018
• 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