MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66CM

Catalog Number CT80STPDVI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Dizziness (2194); Numbness (2415)

Event Date 10/26/2023

Event Type  Injury  

Event Description

Angiodynamics received a user medwatch reference mw5148479 an end user reported, via a voluntary medwatch, that a patient, who had a ct w/8fr detached poly cath w/vi smartport, woke up with arm numbness and tingling.The patient went to the er and had a ct scan and labs performed, with life-threatening results; a saddle pulmonary embolism.The patient was med flighted and treated with surgery and blood thinning medications.The patient is experiencing a dry cough and increased shortness of breath.No further details have been provided.

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).

Manufacturer Narrative

The customer's reported complaint description of the patient experienced blood clots in their lungs and multiple issues since having the port implanted cannot be confirmed due to the patient centric nature of the serious adverse event (sae).No port or catheter tubing product was returned to angiodynamics for evaluation since there was no reported port device malfunction or performance issue, just patient sae of blood clots.Thrombosis/thromboembolism is cautioned in the device dfu as potential complication for an implanted port system.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 (14608102-01) which is supplied to the user with this catalog number, contains the following statements: warnings: absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.A blood return should be present prior to usage of device for any therapy or testing.If the patient complains of pain, or if there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Precautions: · for peripheral placement, irritation to the vein, resulting in postoperative thrombophlebitis, has been associated with guidewire and introducer insertion.When using percutaneous introducers: to avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel without the internal support of a catheter or dilator.If more than one drug is to be administered, between the individual drug applications, flush the system with 5 to 10 ml normal saline for injection to prevent drug interactions.After any infusion, injection or bolus application, the system should be flushed with normal saline for injection or locked with a heparin solution per institutional protocol to prevent thrombotic occlusion of the catheter.Potential complications: use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: these complications are well documented in literature and should be considered when a venous access device is utilized.Air embolism, clot formation, fibrin sheath, infection, inflammation, thromboembolism, thrombosis.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
• Type of Device: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66CM
• 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: 18487105
• MDR Text Key: 332603589
• Report Number: 1317056-2024-00011
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPDVI1
• UDI-Public: H787CT80STPDVI1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CT80STPDVI
• Device Lot Number: A1923003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 124 KG