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

Catalog Number CT80STPDVI

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An end user reported an issue with a ct w/8fr detached poly cath w/vi smartport.The following was reported: "we placed a smart port in a patient on (b)(6) 2023.Patient was not scheduled to have his first treatment till the 6th.When chemo nurse tried using port she noticed that there was swelling in tissue around port when injecting saline and she could not get any blood return.She contacted us to see if we could check it and our dr.Said to get a cxr.Report."the heart size appears mildly enlarged.Right lung appears clear and well expanded.The access portion of a right transvenous mediport is seen but the tube is not visible at this time." it was discovered on the chest x-ray that the catheter was no longer attached to port.Therefore that day we had patient check in to same day procedures so we could look for catheter and retrieve it.Surgical component: the right groin was prepped and draped.Report." using ultrasound guidance, the right common femoral vein was punctured.A guide wire was inserted.A sheath was placed.A 7-french snare was advanced into the mid ivc.The detached chemo port catheter component was snared.The catheter was removed via the femoral sheath.Hemostasis was obtained with compression.A sterile dressing was applied." we had the patient return on the 8th to remove the port itself and replace it.When pocket was opened we found the blue locking mechanism still on metal hub of port with catheter tip still attached.It was like the white portion of the polyurethane catheter just split in two.Dr.(b)(6) had the resident physician test the new port after we had assembled it by pulling on the catheter to make sure it was snug.And this catheter did the same thing.The white portion of the blue catheter broke away from the blue part of catheter almost like they were not bonded correctly in process of making them.So, at this time i said let me check the lot numbers and see if they were the same.And they were.I had three more on shelf with same lot number so i pulled them, and we will not place these in patients.".

Manufacturer Narrative

The customer's reported complaint description of catheter tubing was detached was confirmed based on evaluation of the returned complaint sample.The white tip of the catheter tubing was connected to the port housing and detached at the 1cm mark, i.E.The bond joint with the catheter tubing.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.Engineering evaluation: the septum appears used.The port stem measures in specification for dim e 0.078 +0.007/- 0.000".The catheter tubing was assembled backwards on the port housing.This port device is sold with catheter tubing/blue boot and port housing detached; the end user makes the final connection during the port placement procedure.The customer's reported complaint description of catheter tubing fractured and detached is confirmed, however, the end user assembled the catheter tubing backwards onto the port housing.This catheter tubing has a distal tip end (white) which is at the 0-1 cm marking and is different than the remainder of the light blue catheter tubing.The blue boot was not returned, but this is a likely potential situation given that the blue boot is assembled onto the catheter tubing (by angiodynamics) with the tapered end of the blue boot pointing toward white distal tip.The smartport dfu (14608102-01a) contains the following statements regarding 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 excess catheter by cutting squarely across the distal end.Do not trim catheter at an angle since this could cause the catheter tip to seal off against the side of the vessel.- 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." the end user error in connecting the white distal tip of the catheter tubing to the port housing is the likely root cause of this catheter tubing fracture and detachment event.The remaining catheter was found to measure within the specification.Labeling review: the instructions for use (14608102-01) which is supplied to the user with this catalog number, contains the following statements: potential complications: catheter disconnection or migration and surgical complications.Implantation of attachable catheter (venous/vascular): trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.Blue strain relief mechanism: 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.- 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.Potential complications: catheter fragmentation and catheter pinch-off.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.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 pr(b)(4).

• Brand Name: SMART PORT CT
• Type of Device: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE
• 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: 18444429
• MDR Text Key: 331905819
• Report Number: 1317056-2024-00003
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CT80STPDVI
• Device Lot Number: A2023005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 03/03/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male