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

Catalog Number CT80LPPDVI

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Foreign Body In Patient (2687); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

The reported device is not available to be returned to the manufacturer.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

Angiodynamics received a legal summons regarding an 8f low profile plastic vortex port detached poly catheter filled sh valved introducer.The following was reported: on or about (b)(6) 2023, plaintiff underwent placement of an angiodynamics bioflo vortex port.The device was implanted by dr.Taha mallick, m.D., at tug valley arh in south williamson, kentucky, for the purpose of providing chemotherapy.On or about (b)(6) 2023, plaintiff presented himself to tug valley arh for port removal due to fluid leakage associated with the bioflo vortex.During removal of the defective device, plaintiff's medical team discovered the catheter had disconnected from the port and could not be located.Plaintiff was immediately transferred to pikeville medical center to undergo an additional procedure to locate and remove the catheter fragmen t.Plaintiff underwent retrieval of the dislodged catheter that migrated to the superior vena cava extending through the right atrium into the right ventricle.The catheter fragment was retrieved by dr.Steven j.Krohmer, m.D., at pikeville medical center in pikeville, kentucky.As a result of having the bioflo vortex implanted, plaintiff has experienced significant mental and physical pain and suffering, has sustained permanent injury, permanent and substantial physical deformity, has undergone corrective surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, and present and future lost wages.".

Manufacturer Narrative

The customer's reported complaint description of catheter had disconnected from the port could not be confirmed since no port/catheter complaint sample was returned to angiodynamics.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.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) item number 14600340-01 that is provided in the reported kit contains the following directions and precautions: 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.· 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: · 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.Potential complications use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: catheter occlusion, malposition, dislodgement, fragmentation, migration, disconnection or rupture connecting the catheter a.Place catheter lock onto catheter.The catheter lock is bi-directional and can be mounted on the catheter in either direction.B.Trim the catheter to proper length at a 90° angle allowing sufficient slack to permit body movement, port connection and verify that the catheter is not kinked.C.Advance catheter over port stem to the midway point, slightly past the barb.D.Advance catheter lock until it engages with tactile and/or audible feedback.Note: to ensure proper assembly of port and catheter lock connector, a minimal gap (less than 0.5 mm) is expected.Note: if the catheter and locking collar are connected and then disconnected, the catheter proximal end must be re-cut to ensure a safe re-connection to the port.Precaution: prior to advancing the catheter lock connector, ensure that the catheter is properly positioned.A catheter not advanced to the proper region may not seat securely and lead to dislodgement and extravasation.The catheter must be straight with no sign of kinking.A slight pull on the catheter is sufficient to straighten it.Advancing the catheter lock over a kinked catheter may damage the catheter.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
• Type of Device: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19041022
• MDR Text Key: 339434210
• Report Number: 1317056-2024-00059
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPPDVI0
• UDI-Public: H787CT80LPPDVI0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: CT80LPPDVI
• Device Lot Number: 5666874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Life Threatening; Required Intervention
• Patient Sex: Male