MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO VORTEX PORT; PORT & CATHETER

Model Number CT60LPBDNFVI

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An end user reported an issue with a 6f low profile plastic vortex port.It was reported that the port separated internally, requiring removal and replacement.No additional information was reported.

Manufacturer Narrative

Returned for evaluation was one bioflo vortex port.As received, the port was returned with the catheter tubing and collar still attached and blood was noted to the septum.The catheter appears to be cut between the 4 and 5 cm mark.The rest of the catheter was found to be normal in appearance and measured within specification.No manufacturing defects were observed (device met visual and dimensional specifications).The port-catheter was fluid leak tested with no leaks observed and no detachment of port components.It was observed that the distal end of the catheter tubing was at the 5cm mark vs the typical 0cm distal tip.The tubing at this 5cm mark looks like clean cut and not a fracture of the tubing.In addition, the 5cm mark (now the distal tip end) is 22cm from the port body, which is typical distance between port body and distal tip.It is not suspected that the catheter tubing fractured at this location but that it was trimmed to be distal tip end.The customer's reported complaint description of "port separated internally" was not confirmed.A definitive root cause for this complaint event could not be determined.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (dfu) that is provided in the reported kit contains the following directions and precautions: contraindications catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Warnings: do not use syringes smaller than 10 ml syringe when accessing the port as system damage can occur.Flushing occluded catheters with small syringes can create excessive pressures within the port system.Do not forcefully flush the port system with any syringe size.After confirmation of patency by detecting no resistance and the presence of a blood return, use syringes appropriately sized for the medication being injected.Do not transfer the medication to a larger syringe.Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.A blood return should be present prior to usage of device for any therapy or testing.Do not attempt to measure the patient's blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.If the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Precautions: to avert device damage and/or patient injury during catheter placement: avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.Do not use the catheter if there is any evidence of mechanical damage or leaking.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.Carefully follow the catheter to port connection technique provided in the dfu to ensure proper device connection and to avoid catheter damage.Assure tight connection between port body and catheter.After implantation or any treatment via the port, the system should be flushed with normal saline for injection per institutional protocol.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends reference (b)(4).

• Brand Name: BIOFLO VORTEX PORT
• Type of Device: PORT & CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13549906
• MDR Text Key: 288124038
• Report Number: 1317056-2022-00032
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT60LPBDNFVI0
• UDI-Public: H787CT60LPBDNFVI0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT60LPBDNFVI
• Device Catalogue Number: CT60LPBDNFVI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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