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

Catalog Number	H787PSAX10I0
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Embolism (1829); Patient Problem/Medical Problem (2688)
Date of Event	01/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been indicated that the used port/catheter will be returned for evaluation, but it has not yet arrived.Upon receipt of the device and completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, "on attached port, the connector came off and had to be surgically removed.Also the patient had a cath lab procedure.The physician said the catheter had embolized.".
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the vortex port product family and the failure mode "catheter detached {from port}." no adverse trend was identified.The reported complaint description cannot be confirmed as no sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Multiple attempts to contact the end user for additional details received no response.Per the directions for use (dfu) provided with the vortex port: "use of angiodynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: fibrin sheath, migration, catheter pinch-off (compression of the catheter between the clavicle and the first rib) and catheter fragmentation." regarding catheter placement, per dfu: "(preattached catheter) follow general port placement guidelines described under "port placement considerations" and "percutaneous procedure".A small incision is made in deltopectoral groove to expose cephalic vein or a small transverse incision in neck to expose external jugular vein.Isolate vessel.Introduce catheter through venotomy and advance to desired location.Confirm catheter placement by appropriate radiographic technique.3.Anchor catheter at venotomy site.Avoid excessive suture tightness to prevent catheter occlusion.Caution: sufficient slack should be left between port and catheter insertion point to preclude strain on the catheter.When using external jugular vein, carefully position the catheter over clavicle to avoid kinking or occlusion." (b)(4).
Additional Manufacturer Narrative
Additional information received via a legal summons on 11/25/2024.

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED
• 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: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 7274487
• Report Number: 1317056-2018-00013
• Device Sequence Number: 135662
• Product Code: LJT
• UDI-Device Identifier: H787PSAX10I0
• UDI-Public: H787PSAX10I0
• 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: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Physician
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: H787PSAX10I0
• Device Lot Number: 5165411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018; 11/25/2024
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/23/2018; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female