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

Catalog Number	CT80STPDVI
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
An end user reported an issue with a w/8fr detached poly cath w/vi smartport.A few weeks following device implantation, the catheter was found to be fractured inside of the patient.The patient required surgical removal of the fragment.No further details have been provided.
Additional Manufacturer Narrative
No port or catheter tubing product returned to angiodynamics for evaluation.The customer's reported complaint description of catheter tubing fractured inside the patient cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The event description states that the catheter tubing separated from the port "a few weeks" after port implant.It cannot be determined if the catheter tubing itself fractured or if the catheter tubing disconnected from the port housing.The end user makes the catheter-to-port connection during the placement procedure for this port upn.In addition, "a few weeks" is a very short period of time for a flexural fatigue failure of the catheter tubing, i.E.Pinch-off syndrome.Another potential root cause is end user connecting the distal tip end of the catheter tubing to the port housing (i.E.Connecting the catheter tubing backwards).The distal tip end (1cm) is bonded to the catheter tubing and this junction can be a fracture location if connected to the port housing.A potential root cause is the catheter tubing disconnected from port housing due to unsecure connection and/or connecting catheter distal tip to port housing during the port placement procedure.In lieu of a reported lot number, a ship history report (shr) was generated for item number (b)(4) in order to ascertain the last three lots shipped to the reporting customer in the six (6) months prior to the procedure date.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, 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
• Common Device Name: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X
• 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: 18041474
• Report Number: 1317056-2023-00145
• Device Sequence Number: 8143630
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPDVI1
• UDI-Public: H787CT80STPDVI1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CT80STPDVI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown