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

Model Number	CT80LPBDVI
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a 8f low profile plastic vortex port detached bioflo catheter.During a procedure, while the patient was under general anesthesia, upon accessing the vessel with the introducer, the physician advanced the guidewire into the introducer needle.It was advanced, approximately 1" into the vessel, and then would not advance further.The physician attempted to withdrawn the guidewire out of the introducer needle; however, it was stuck.The needle and guidewire were removed as one unit.It was reported the guidewire appeared intact, and was only "stuck" inside the needle.Due to this issue, and no additional kits available, the procedure was cancelled the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.This event meets the criteria a reportable adverse event; patient safety risk as treatment was not provided, but patient had been sedated.
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was one guidewire and one needle.As received, the guidewire was stuck inside the needle as reported by the customer.The guidewire accessory is supplied to (b)(4) by the supplier (b)(4).Scar004530 and the returned guidewire/needle sample were sent to (b)(4) for sample evaluation/root cause analysis and dhr review of supplier lot.As per scar004530 response from lake region medical, at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "improper handling", "improper use", "excessive force used", "user failure in preparations for use" and "improper removal from packaging" may have impacted on the event as reported.No discrepancies were noted.The customer's reported complaint description of guidewire stuck in needle was confirmed via visual evaluation of the returned guidewire/needle sample.Although the complaint description was confirmed, a defnitive root cause for the reported event cannot be determined.A potential root cause is end user pulling guidewire back against the needle, damaging the guidewire.This is cautioned against per the device dfu.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: directions for use are provided with this device and contain the following statements: precaution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit to help prevent the needle from damaging or shearing the guidewire.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: 13840064
• Report Number: 1317056-2022-00059
• Device Sequence Number: 4731614
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPBDVI0
• UDI-Public: H787CT80LPBDVI0
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K010767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 02/29/2024
• Device Model Number: CT80LPBDVI
• Device Catalogue Number: CT80LPBDVI
• Device Lot Number: 5666871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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: 26 YR
• Patient Sex: Female
• Patient Weight: 86 KG