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

Model Number CT66LTPD-VI

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

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

An event that occurred with a patient that had a previously removed port from a tandem ct lowprofile with valved introducer smartport kit.On (b)(6) 2023, a patient underwent bilateral mastectomy and left mediport removal.Patient no longer required the port because chemotherapy was completed.On (b)(6) 2023, the patient returned to the or for re-excision of right breast.An intra-operative x-ray was done.X-ray showed mediport metallic cuff retained from previous surgery.Patient and family member were notified, consent was obtained, and retained medi-port piece was removed.Patient and surgeon confirmed that retained piece could be palpated.

Manufacturer Narrative

Returned for evaluation was one (1) 6.6 locking collar.No visual defects or damage were noted to the locking collar.The returned locking collar was inspected per incoming op code and determined the product meets specification.The dim a (overall length), dim b (od), dim d (through hole id) and dim c/g of the locking collar was confirmed to meet device specification per drawing.The customer's reported complaint description of locking collar was inadvertently retained in port pocket during the port explant procedure on (b)(6) 2023 cannot be confirmed given the nature of this patient adverse event.The locking collar was removed from the patient on (b)(6) 2023 during a subsequent procedure and was returned to angiodynamics for evaluation.No supplier related manufacturing non-conformance was observed during investigation of the locking collar; component met all dimensional inspections per drawing.A device history record review of the packaging, port assembly, catheter tubing and locking collar lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The catheter and locking collar are provided as a separate components within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with locking collar) during the implantation procedure.The directions for use provided with this port device states: "slide the locking mechanism over the proximal end of the catheter, leaving 1 to 2 cm of catheter protruding.Advance the catheter completely over the stem.Slide the lock up to the port body and "snap" into the port." there were no reports of port device malfunction (e.G.Leaks, catheter disconnection) during the treatment use period of (b)(6) 2022 to (b)(6) 2023.The port was being explanted due to end of treatment.Based on the information provided and the evaluation of the returned locking collar, the root cause for the locking collar being retained in the patient's port pocket during the explant procedure on (b)(6) 2023 is end user error in not removing all components of the port device.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.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.After implantation and during system use each access to the vortex® mp port system should be performed using aseptic technique.Use only non-coring needles with the vortex® mp port system.The noncoring needle design helps maintain the self-sealing septum.Under qualified procedures the vortex® mp port system allows up to 2,000 punctures with an angiodynamics® 22 gauge noncoring needle, when tested at 10 psi.This pressure exceeds the typical levels experienced in clinical practice.Do not use a syringe smaller than 10 ml.Smaller syringes may create an over-pressurized condition in the system.Warning: for chest placement, avoid medial catheter placement instructions for implantation of the vortex® mp port 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 to the subclavian vein.Potential complications: use of angiodynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: infection; occlusion; thrombophlebitis, pneumothorax; catheter malposition; migration and inadequate anchoring; hemorrhage; vessel trauma, including puncture, laceration, and erosion of vessel and the skin; catheter pinch-off (compression of the catheter between the clavicle and the first rib); hematoma; clot formation; catheter fragmentation; embolization; cardiac arrhythmia; cardiac puncture; cardiac tamponade; fibrin sheath, endocarditis; implant rejection; thoracic duct injury; thromboembolism; peritonitis; thrombosis; and drug extravasation (leakage).One step locking mechanism: slide the locking mechanism over the proximal end of the catheter, leaving 1 to 2 cm of catheter protruding.Advance the catheter completely over the stem.Slide the lock up to the port body and "snap" into the port.J.Secure port body to underlying fascia using non-absorbable sutures and a minimum of three suture sites.Care should be exercised so that incision does not cross septum of port after closure.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: 16645609
• MDR Text Key: 312429534
• Report Number: 1317056-2023-00028
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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: 5740791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 65 KG