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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGONGMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER
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VYGONGMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 1261.20
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Pleural Effusion (2010)
Event Date 06/22/2023
Event Type  malfunction  
Manufacturer Narrative
The report states a sample will be received for evaluation and an investigation will be completed at that time.
 
Event Description
Patient of 31+2 weeks gestational age with a diagnosis of neonatal sepsis, on high-frequency ventilation, presenting with flushing, erythema and crusting in the left hemithorax including the patient's shoulder.In that extremity she has an epicardial epicutaneous catheter which was inserted on 16/06 fixed at 11 cm, a chest x-ray was performed in which pleural effusion and pleural catheter were found.Pleural effusion and well positioned catheter (central), the liquid is drained from the pleural space and it is found to be parenteral nutrition.The technovigilance area did not find any defect that could have caused the event.
 
Event Description
Patient of 31+2 weeks gestational age with a diagnosis of neonatal sepsis, on high-frequency ventilation, presenting with flushing, erythema and crusting in the left hemithorax including the patient's shoulder.In that extremity she has an epicardial epicutaneous catheter which was inserted on 16/06 fixed at 11 cm, a chest x-ray was performed in which pleural effusion and pleural catheter were found.Pleural effusion and well positioned catheter (central), the liquid is drained from the pleural space and it is found to be parenteral nutrition.The technovigilance area did not find any defect that could have caused the event.
 
Manufacturer Narrative
The failed sample has not been returned to the manufacturer for evaluation.Therefore, the results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.
 
Manufacturer Narrative
The failed sample has not yet been received by the manufacturer for investigation.Therefore, the results of this investigation are still pending.
 
Event Description
Patient of 31+2 weeks gestational age with a diagnosis of neonatal sepsis, on high-frequency ventilation, presenting with flushing, erythema and crusting in the left hemithorax including the patient's shoulder.In that extremity she has an epicardial epicutaneous catheter which was inserted on 16/06 fixed at 11 cm, a chest x-ray was performed in which pleural effusion and pleural catheter were found.Pleural effusion and well positioned catheter (central), the liquid is drained from the pleural space and it is found to be parenteral nutrition.The technovigilance area did not find any defect that could have caused the event.
 
Event Description
Patient of 31+2 weeks gestational age with a diagnosis of neonatal sepsis, on high-frequency ventilation, presenting with flushing,erythema and crusting in the left hemithorax including the patient's shoulder.In that extremity she has an epicardial epicutaneous catheter which was inserted on (b)(6) fixed at 11 cm, a chest x-ray was performed in which pleural effusion and pleural catheter were found.Pleural effusion and well positioned catheter (central), the liquid is drained from the pleural space and it is found to be parenteral nutrition.The technovigilance area did not find any defect that could have caused the event.
 
Manufacturer Narrative
This complaint is not confirmed.The returned complaint form was describes the incident as follows: "patient of 31+2 weeks gestational age with a diagnosis of neonatal sepsis, on high-frequency ventilation.Frequency ventilation, presenting with flushing, erythema, and crusting in the left hemithorax including the patient's shoulder.In that extremity, she has an epicardial epicutaneous catheter which was inserted on (b)(6) fixed at 11 cm, a chest x-ray was performed in which pleural effusion and pleural catheter were found.Pleural effusion and well-positioned catheter (central), the liquid is drained from the pleural space, and it is found to be parenteral nutrition.We received a complete catheter code 1261.20 of 20 cm in length.The sample was used and cleaned by the hospital.The catheter was flushed with warm water to check for a leak, but no leak was found.Then we tested the catheter with the innomatec leak tester at 1.5 bar.The catheter also passed this test used in production without showing any leak.The sample complied with its specifications and was free of any defects.The user's descriptions of the incident: "pleural effusion and well-positioned catheter (central)" and "a chest x-ray was performed in which pleural effusion and pleural catheter were found" are contractional: the catheter was fully functional, but obviously migrated from a central position into a wrong position causing the pleural effusion (pleural catheter).In the product's ifu we emphasize: "precautions: the catheter tip must not be advanced into the heart (right atrium).The location of the catheter within the heart may cause cardiac tamponade or cardiac arrhythmias.It is necessary to make checks of the catheter tip position at regular intervals throughout the usage of the catheter.".Having checked the batch history records, no deviations were found.The batch complied with its specifications and was released.Each catheter is leak and flow tested during production.The tensile force of the catheter components is randomly checked.Visual tests are carried out for product/component presence, the presence in cavities, and the integrity of the product seal.We received two complaints for batch no.250822gl, but the other one was related to a different reason of the complaint.This is the first complaint regarding a pleural effusion on code 1261.20 within the last three years.This query covers all complaints that have come to our attention worldwide.No further corrective action was initiated by quality management as the catheter returned was free of defects and worked well for 6 days before the patient's condition deteriorated.No hints of a manufacturing fault could be found.Thus, as vygon, we do not take responsibility for this complaint.
 
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Brand Name
PREMICATH
Type of Device
LONG-TERM INTRAVASCULAR CATHETER
Manufacturer (Section D)
VYGONGMBH
prager ring 100
aachen, 52070
GM  52070
Manufacturer (Section G)
VYGONGMBH
prager ring 100
aachen, 52070
GM   52070
Manufacturer Contact
freda lacroix
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key17369641
MDR Text Key320257062
Report Number2245270-2023-00044
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K954302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 10/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1261.20
Device Lot Number250822GL
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2023
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 Number1
Patient Outcome(s) Required Intervention;
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