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

Model Number CT75STSA

Device Problem Fracture (1260)

Patient Problems Infiltration into Tissue (1931); Foreign Body In Patient (2687)

Event Date 04/19/2023

Event Type  malfunction  

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 Description

The patient had a smartport, from a tandem ato ct vtx sltit 7.5 att kit, placed for chemotherapy treatment due to pancreatic cancer.The port was placed left subclavian.4 months post placement, it was reported that the port "stopped working", so the patient went in for imaging.Under imaging, it could be seen that the catheter line had fractured and had migrated to the patient's pulmonary trunk into the pulmonary arteries.The patient then underwent explantation on (b)(6) 2023 and had a new port was inserted.The port body and attached portion of the catheter were removed at that time.This meant that there was a delay in chemotherapy access, potentially progressing the disease.A change in medication (anticoagulation) was also required, adding further risks to the patient.The patient still requires an additional procedure in a tertiary centre to remove the fractured line that has migrated.The replacement procedure had not been performed at the time of this report.

Manufacturer Narrative

Returned for evaluation was one (1) smartport with catheter tubing attached.The fractured/detached end of the catheter tubing (17cm mark) is oval in appearance indicating that the fracture was due to flexural fatigue of the tubing.This is indicative of the flexing that occurs during pinch-off syndrome (between clavicle and first rib when catheter is place sub-clavian).The fracture location being ~14cm from the port body is a little longer distance than normal for pinch-off, however, this would make sense if place in a larger adult; patient is 47-year-old male, but weight was not provided.No manufacturing non-conformances were observed during complaint sample evaluation and many indicators point to pinch-off syndrome being likely root cause for this event.The customer's complaint description of catheter fracture is confirmed.The likely root cause for this event is pinch-off syndrome, which is cautioned in the device dfu as potential complication.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.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.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: 16932237
• MDR Text Key: 315306614
• Report Number: 1317056-2023-00061
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSA0
• UDI-Public: H787CT75STSA0
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

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 Expiration Date: 04/30/2023
• Device Model Number: CT75STSA
• Device Catalogue Number: CT75STSA
• Device Lot Number: 5732117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 07/29/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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: 47 YR
• Patient Sex: Male