MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; PORT & CATHETER,

Catalog Number	CT75STSD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the reported 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 physician reported that a patient is experiencing a "true allergy' to a single titanium ct vtx port, w silc catheter.The physician was inquiring what type of materials the port is comprised of and noted that the patient has been sent for further allergy testing.These results are still spending.The patient was treated with oral and topical steroids for one month but ultimately had the port removed.Once the port was removed, the rash resolved within 24 hours and the patient is doing well.
Additional Manufacturer Narrative
In emdr follow up #1, section h2 was inadvertently left blank."additional information" should have been checked.
Additional Manufacturer Narrative
The customer's reported complaint description of patient experienced an allergic reaction to the port implantation cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port or catheter tubing was returned for evaluation since there was no report of device malfunction.Doctor sent patient for allergy testing but no results were provided to angiodynamics, despite multiple good faith effort requests.The directions for use (dfu) for this port kit does contraindicate its use for the presence of allergic reaction materials contained in the device and cautions that implant rejection/inflammation is a potential complication from this implantable device.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 16608102-01 that is provided in the reported port kit contains the following statements: contraindications: presence or suspicion of allergic reaction to materials contained in this device.Demonstrated intolerance for an implanted device.Potential complications: implant rejection, inflammation.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: SMART PORT
• Common Device Name: PORT & CATHETER,
• 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: 18256649
• Report Number: 1317056-2023-00171
• Device Sequence Number: 6685378
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2024

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: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: CT75STSD
• Device Lot Number: A2323002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/12/2024; 02/12/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/27/2024; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Female