MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX MP VASCULAR ACCESS PORT; VORTEX¿ MP VASCULAR ACCESS PORT,

Catalog Number	SSAX16I
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A legal firm reported an adverse event associated with a triumph vortex port att w/ 10f intro kit pg.The following was reported: -on or about (b)(6) 2021, plaintiff underwent imaging, which demonstrated a catheter fracture.The fragment was positioned in the base of plaintiff's right atrium and right ventricle.- on or about (b)(6) 2021, plaintiff presented herself to (b)(6) medical center in (b)(6) for fragment retrieval.After multiple attempts, plaintiff's medical team were unable to retrieve the catheter fragment.-on or about (b)(6) 2021, plaintiff underwent a second surgery to remove the catheter fragment from her right atrium and right ventricle.After multiple attempts, plaintiff's medical team were once again unable to retrieve the fragment.Plaintiff was referred to an interventional cardiologist for further assessment and treatment.-on or about (b)(6) 2021, plaintiff presented herself to (b)(6) hospital in (b)(6) for fragment retrieval.After multiple attempts, plaintiff's medical team were unable to retrieve the catheter fragment.-on or about (b)(6) 2022, plaintiff returned to (b)(6) for a follow-up appointment, where her medical team determined that the risks of further attempts to remove the catheter fragment were too high; the catheter fragment remains inside of plaintiff.Plaintiff has suffered and will continue to suffer physical pain and mental anguish.Plaintiff has also incurred substantial medical bills due to the defective product that was implanted in her body.
Additional Manufacturer Narrative
The customer's reported complaint description of catheter tubing detached cannot be confirmed, no complaint sample was returned.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 instructions for use, (16605362-01) which is supplied to the user with this catalog number, contains the following statements.Catheter placement considerations: warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.After implantation and during system use each access to the vortex® mp port system should be performed using aseptic technique.Use only non-coring needles with the vortex® mp port system.The noncoring needle design helps maintain the self-sealing septum.Under qualified procedures the vortex® mp port system allows up to 2,000 punctures with an angiodynamics® 22 gauge noncoring needle, when tested at 10 psi.This pressure exceeds the typical levels experienced in clinical practice.· do not use a syringe smaller than 10 ml.Smaller syringes may create an over-pressurized condition in the system.Warning: for chest placement, avoid medial catheter placement instructions for implantation of the vortex® mp port into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route to the subclavian vein.Note: a port placed too deeply may be difficult to palpate and access.Potential complications use of the system involves potential risks associated with any implanted device or indwelling catheter.They include, but are not limited to: extravasation catheter fracture, including "pinch-off syndrome" 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 MP VASCULAR ACCESS PORT
• Common Device Name: VORTEX¿ MP VASCULAR ACCESS PORT,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18242402
• Report Number: 1317056-2023-00166
• Device Sequence Number: 6685907
• Product Code: LJT
• UDI-Device Identifier: H787SSAX16I0
• UDI-Public: H787SSAX16I0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: SSAX16I
• Device Lot Number: 5174381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female