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

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

Patient Problem Infiltration into Tissue (1931)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

A distributor reported being made aware of an incident involving a smartport ct during the device removal procedure at end of treatment.Upon mobilisation of the port head from the side chest wall and freeing of the fibrous sheath around the port and line, the port catheter was unable to be pulled out.It reportedly "felt as if the line was stretching but not moving out." a 2-3cm neck incision was required to be made just proximal to the insertion site into the r ijv.The sheath around the line in the neck was freed, and the line was pulled out of the patient's neck.Further freeing of the sheath was required in order to pull the line out from the chest wall incision.The line, reportedly, looked rough and ragged, and almost felt as it was partly disintegrated, although this is unclear if it was from the pulling in the attempts to remove the line.The port was accessed approximately ever 2 weeks for sampling, anesthesia administration and chemotherapy treatment.

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).

Manufacturer Narrative

Returned for evaluation was one (1) smartport.As received, the catheter tubing was attached to the smartport.The catheter tubing appeared to be discolored {pinkish} and have a rough exterior surface.The catheter contained a kink/bend at the 38cm and the 42cm marks.Engineer evaluation: the returned catheter was observed to have rough surface on the exterior of the catheter for almost the entire length.  in addition, a fibrous/fibrin sheath was reported by the end user (which is common for an indwelling catheter).  the catheter's rough exterior surface and presence of fibrin sheath likely contributed to the difficult to remove catheter event experienced during the port explant procedure.However, we are unable to determine an exact root cause for the catheter's rough exterior surface.  no manufacturing related non-conformances were observed during evaluation of the returned port/catheter tubing and the catheter met dimensional specifications.  port placement, patient anatomy and drugs used during the 2.5-year treatment are potential contributing factors of the rough catheter surface and the difficult to remove catheter tubing.The customer's reported complaint description of the catheter was difficult to remove during explant procedure (end of device use/treatment) was confirmed as the exterior of the catheter tubing had a rough surface indicating it was adhered to tissue or the reported fibrous/fibrin sheath.A definitive root cause for the customer experience with this device could not be determined.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 catalog 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.Potential complications: catheter fragmentation and catheter pinch-off.Catheter placement considerations: warning: avoid medial catheter placement into sub-clavian 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 (b)(4).

Event Description

Additional information provided reported the following: patient's initials: am.The patient had not experienced any previous venous thrombosis.The patient had received 6 cycles of chemotherapy for acute lymphoblastic leukaemia.

• Brand Name: SMART PORT
• Type of Device: PORT & CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15737848
• MDR Text Key: 307184259
• Report Number: 1317056-2022-00131
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female