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

Model Number CT66LTPD-VI

Device Problems Inability to Irrigate (1337); Failure to Infuse (2340)

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

Event Date 12/21/2022

Event Type  malfunction  

Event Description

A clinical specialist reported a patient experienced with a smartport from a tandem ct lowprofile with valved introducer smartport kit.The cs received a call from the patient, and then the patient provided an email with the following information: the physician who ordered the port was dr.(b)(6).The physician who placed the port on (b)(6) 2022 was dr.(b)(6) with their resident physician (b)(6).Between 09/02 and 12/17, she had 4 emergency room visits due to issues with the port not flushing, access, and resistance.It's overwhelmingly frustrating having to miss work plus school to go to the emergency room to get the port flush plus having to sit there 18 plus hours only to be told by the emergency room they cannot do anything.Then miss a day of work to get a procedure done to get the port checked out, not once to have it placed ((b)(6) 2022), not twice to have it evaluated in ir ((b)(6) 2022), but now three times to have it replaced on (b)(6) 2023.On (b)(6) 2022 - physician (b)(6) ordered an ir cvad reservoir repair / port evaluation due to the emergency room being unable to flush the port on (b)(6).Emergency room had tried various times to access and flush port with nothing but resistance.Emergency room doctor stated he did not want to continue and possibly risk the port busting.Emergency room doctor then sent up in order to interventional radiology to have the port evaluated with contrast and ct.Timeline summary: (b)(6) 2022 port placed, (b)(6) 2022 access, difficulty flushing, treatment was provided at emergency room , (b)(6) 2022 unsuccessful attempts for treatment at infusion center, (b)(6) 2022 3 unsuccessful attempts to flush at emergency room , (b)(6) 2022 unable to flush, (b)(6) 2022 ir evaluation, (b)(6) 2023 scheduled port replacement.

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.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was one (1) port with catheter tubing.Device was received with catheter tubing connected to port and was able to flush and aspirate fluid with no difficulty.It was observed that the catheter tubing had a flat spot between the 7-8 cm markings (with the 0 cm marking end connected to the port housing).The patient's reported complaint description of port-catheter device was difficult to flush and aspirate was not confirmed during functional testing of the returned port complaint sample.The flat spot on the catheter tubing at the 7-8 cm markings is consistent with the catheter tubing being kinked/pinched.This is generally a result of "pinch-off" syndrome when the catheter tubing is placed via sub-clavian vein, however, it was reported that port was placed via right internal jugular (ij).Kinking of the catheter tubing can occur when placed via the ij.There is no indication of a device malfunction or manufacturing non-conformance that contributed to the fluid flow issues but rather the placement of the catheter tubing such that the tubing became kinked/compressed at the 7-8 cm marking location.A definitive root cause for the reported complaint description is unable to be determined, however, the likely root cause of the fluid flow issues with this device is the pinching/flat spot on the catheter tubing between the 7-8 cm markings.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.Pinch-off syndrome: pinch-off syndrome signs may include difficulty in aspirating blood, resistance to flushing or infusion of medications or fluids that improves with position changes, infraclavicular pain and/or swelling with catheter flushing or infusion palpitations, sudden onset chest pain, cardiac arrhythmias, extra heart sound, chest wall swelling at the port pocket, vein insertion site, pain in shoulder or port area not associated with swelling, cough, paresthesia of arm on side of catheter withdrawal occlusion or swishing sound with catheter flushing.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.Note: if infusion or aspiration is successful upon lifting arm above the head and turning the head, consider pinch-off syndrome as a possible cause.The line should be radiologically evaluated if pinch-off syndrome is suspected.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: PORT & CATHETER,
• 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: 16273427
• MDR Text Key: 308614927
• Report Number: 1317056-2023-00011
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPDVI1
• UDI-Public: H787CT66LTPDVI1
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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 Model Number: CT66LTPD-VI
• Device Catalogue Number: CT66LTPDVI
• Device Lot Number: 5738677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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 Age: 32 YR
• Patient Sex: Female
• Patient Weight: 103 KG