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

Model Number 1261.20G

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

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Line was placed on (b)(6) 2021 planned removal (b)(6) 2021 when removing the line 19cm was expected and only 14 cm was removed.

Manufacturer Narrative

Correction: the model number should be 1261.20g.The previous initial report listed 1262.20g erroneously.We received a catheter connected to a 3 ml posiflush syringe.The catheter obviously snapped at 4.7 cm.The catheter showed severe occlusion and therefore was not possible to be flushed.A microscopic examination showed a rough, uneven breakage section at the tip of the catheter.Furthermore, there were signs of elongation up to the 7 cm marking of the catheter tube.The involved catheter had been in use for 44 days.When removing the catheter, it should be done by gentle traction close to the insertion site with a slow and steady motion.There is a statement in our product ifu: caution: if difficulty is experienced when removing the catheter, do not apply excessive traction, and stop removal.Use ultrasound along the catheter pathway to analyze the reason for catheter removal blockage.A warm compress above the catheter pathway encourages vasodilation.A gentle vein mobilization at the skin surface may help.Retry removal at a later date if removal is still unsuccessful.Follow your hospital protocol for difficult catheter removal.A review of the batch history records was performed, and no deviations were found.The batch complied to its specification and was released.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out with no exceptions found.The mean value of the tensile force of the involved catheter tube was 6 n and therefore within our specification (minimum acceptable value is 3 n).There is one additional complaint for batch 8138570 but this is the first complaint regarding a snapped catheter tube away from the wing on code 4g07126120.This type of defect is included in the risk analysis and its occurrence rate, and the risk evaluation is acceptable.No further corrective action initiated by quality management as there is no hint for a manufacturing fault and the catheter worked well for 44 days.Corrective action: no further corrective action initiated by quality management due to this complaint, as this catheter worked well for 44 days and there are no indications of a manufacturing fault.

Event Description

Line was placed on (b)(6) 2021 planned removal (b)(6) 2021 when removing the line 19cm was expected and only 14 cm was removed.

• Brand Name: PREMICATH
• Type of Device: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 13001372
• MDR Text Key: 283750877
• Report Number: 2245270-2021-00128
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1261.20G
• Device Lot Number: 21F010D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 03/15/2022
• 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