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

Model Number 1261.203

Device Problems Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)

Patient Problems Pleural Effusion (2010); Perforation of Vessels (2135)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

The device will be returned to the manufacturer for device evaluation and complaint investigation.Upon completion of the investigation, the results will be forwarded to fda via follow-up mdr with 30 days.

Event Description

Catheter placed in shoulder; perforation of little vein which causes a pleural effusion of 50 ml.

Manufacturer Narrative

"examination of the faulty sample returned (the catheter's tip) showed that the customer had cut off the catheter's tip at 41 mm.The fragment showed typical striations from cutting.Besides the cut no further damage was found on the fragment.This is the first complaint regarding pleural effusion for batch no.040914gh (more than (b)(4) ea distributed) and the second complaint for this reason of failure within the last 3 years.Pleural effusion is a well-known complication in cvc placement and therefore is mentioned as possible complication in the premicath's ifu.Unfortunately no further information about this incident was obtained from the customer.".

Event Description

Catheter placed in shoulder; perforation of little vein which causes a pleural effusion of 50 ml.

• 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: jillian mikovich ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 5128787
• MDR Text Key: 27522326
• Report Number: 2245270-2015-00087
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1261.203
• Device Lot Number: 040914GH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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