MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX PORT; VORTEX LP DUAL TITANIUM PORT SYSTEM

Model Number	LVTX5213
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an event that occurred with a lp titanium vtx 12 fr det 12f intro port.The patient had significant access issues with his port.His lateral port was accessed, flushed and pulled with no issue.The medial port would not flush or draw.A contrast study under flouro was performed which showed a retained catheter fragment in the distribution of the left brachiocephalic vein left from a previously removed unknown port.Under flouro, they attempted to infuse contrast, however only a short segment of the external catheter associated with the access needle filled with contrast material, after which resistance precluded a contrast extending more distally into the hub itself.After documenting this, the examination was terminated.The patient was returned to his room, and a np performed arbcx with the lateral port out of the patient and peripheral access into the patient.The patient was discharged home with usage instructions.The patient has been scheduled for (b)(6) 2022 for removal and replacement as the patient requires both hubs to be functional for treatment.
Additional Manufacturer Narrative
The reported device is currently implanted with plans for removal, therefore is currently unavailable for return for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was one dual lumen port.As received the port contained bio material {blood} inside and outside.Both sides of the port septum were filled with bio material {blood}.The port stem was found to be occluded with a piece of material that appeared to have been cored out of the septum.The customer's complaint description of inability to infuse or aspirate through one side of the port is confirmed.The port stem was found to be occluded with a piece of material that appeared to have been cored out of the septum.The most likely root cause of this issue is use of an incompatible (coring) needle or damaged needle resulting in a cored section of the septum being pushed inside the port and lodging in the port stem/lumen.No manufacturing non-conformances were observed during sample review.Dfu instructs the use of anti-coring needle for port access.The customer's complaint description of inability to infuse or aspirate through one side of the port is confirmed.The port stem was found to be occluded with a piece of material that appeared to have been cored out of the septum.The most likely root cause of this issue is use of an incompatible (coring) needle or damaged needle resulting in a cored section of the septum being pushed inside the port and lodging in the port stem/lumen.No manufacturing non-conformances were observed during sample review.Dfu instructs the use of anti-coring needle for port access.Labeling review: review of the returned port sample shows damage to the port septum consistent with coring from needle that in not a non-coring needle.This use of the port device is not consistent with its labeling.Dfu is supplied to the customer.The dfu contains a warning that states: needles use of angiodynamics anti-coring (19 to 22 gauge huber point) needles in all procedures is recommended.These needles have been designed and tested to ensure that septum life is preserved.Needles are for single use only.Note: septum puncture life under qualified testing procedures, the septum allows up to 2,000 punctures when tested at 10 psi using a 22 gauge non-coring needle.This pressure exceeds typical levels experienced in clinical practice.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: VORTEX PORT
• Common Device Name: VORTEX LP DUAL TITANIUM PORT SYSTEM
• 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: 13257977
• Report Number: 1317056-2022-00003
• Device Sequence Number: 19218981
• Product Code: LJT
• UDI-Device Identifier: H787LVTX52130
• UDI-Public: H787LVTX52130
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K010767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: LVTX5213
• Device Catalogue Number: LVTX5213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male