MAUDE Adverse Event Report: ANGIODYNAMICS, INC SMART PORT CT; SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 7.5F X 66CM SILICONE C

Catalog Number H787CT75STSD0

Device Problems Complete Blockage (1094); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

A distributor, medical specialties australasia (msa), reported being notified of the following issue with a single titanium ct vtx port w silc cath: "msa has been notified by our australian regulatory authority (tga therapeutic goods administration), via email, of an incident involving a smartport ct.The name of the healthcare professional and the hospital involved were both redacted by the tga, before notifying msa.Patient was due for monthly treatment that required port access to administer medication.Port/catheter was not able to be aspirated or flushed and was completely blocked.Port-o-gram performed and showed catheter had dislodged and migrated into the pulmonary artery requiring fluoroscopic guided retrieval." despite multiple good faith efforts, no further details have been obtained.

Manufacturer Narrative

The customer's reported complaint description of the catheter detached and migrated to patient's heart cannot be confirmed since no port/catheter complaint sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential root cause is unsecure connection of the catheter to port body or fracture/detachment of the catheter tubing itself.The reported difficulty of flushing and aspirating the port is likely a result of the catheter detachment and not independent port performance issues.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, (16608102-01) which is supplied to the user with this item number, contains the following statements: - 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.Caution: avoid piercing catheter with suture needle.Contraindications · catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Potential complications: catheter fragmentation catheter pinch-off drug extravasation (leakage) 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.The following statements reference making the catheter connection to the port housing: - insert catheter into sheath.Position the distal end of the catheter at the desired location.Peel away sheath while withdrawing it from vessel.Care should be taken not to withdraw catheter as sheath is removed.Catheter position should be confirmed radiographically.Secure catheter in place.- trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.- slide the blue strain relief mechanism over the end of the catheter.The tapered end of the blue strain relief mechanism should point away from the proximal end of the catheter.For optimal results, the proximal end of the catheter should be dry.Slide the trimmed end of the catheter tip onto the stem until the catheter is flush with the stem flanges.Slide the strain relief mechanism over the catheter and onto the stem until it contacts the port body.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 CT
• Type of Device: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 7.5F X 66CM SILICONE C
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18891606
• MDR Text Key: 337750405
• Report Number: 1317056-2024-00049
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: H787CT75STSD0
• Device Lot Number: 5534463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other