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

Model Number '1261.20

Device Problems Break (1069); Material Fragmentation (1261); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device 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.

Event Description

At 23: 30 of (b)(6) 2023; one proceeds to withdraw catheter epicutaneo of the fixed rn 20 cm; tegaderm dressing is humidified and one begins withdrawal of way controlled and paused, immediately initiated the procedure is evidenced resistance on the part of the catheter, more negative pressure that hinders the optimal exit of the same one, one notifies to companion in turn and under its supervision, the withdrawal of slow and controlled way is continued; 12 cm premicath catheter comes out incomplete, leaving 8 cm remaining in the patient's mii, the doctor on duty is notified and abdominal and lower limb x-rays are performed.On (b)(6) 2023 a large vessel exploration (venectomy) + vessel ligation + foreign body extraction was performed without complications by paediatric surgery.

• 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 Key: 18340654
• MDR Text Key: 330667259
• Report Number: 2245270-2023-00085
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K954302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: '1261.20
• Device Lot Number: 020922GL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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