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

Model Number CT80STPD

Device Problems Fracture (1260); Inability to Irrigate (1337); Material Puncture/Hole (1504); Difficult to Remove (1528); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338); Failure to Infuse (2340); Obstruction of Flow (2423); Infusion or Flow Problem (2964); No Flow (2991); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2021

Event Type  Injury  

Event Description

A distributor reported an issue with a single titanium smartport ct that was placed in (b)(6) 2021 and working well.In (b)(6), there was an issue with infusion, prior to chemotherapy treatment.A chest x-ray was performed and showed that the catheter had severed at the port, under/below the blue boot.The distal port was visible in the patient's right atrium; however, a ct scan was later performed and the distal catheter tip had migrated into the right ventricle.Ultimately, the port was removed on (b)(6) 2022 and the portion of the device that migrated, was removed, via snare, through a groin access.To note, the blue boot was still insitu (attached to the port) when the port was removed.It is unknown if the port was replaced.

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).

Manufacturer Narrative

Returned for evaluation was a smartport.As received, approximately 1 cm of the catheter tubing was attached to the port stem.The remainder of the catheter and the blue boot were not attached to the port.The catheter tubing was occluded with dried blood.It was noted that the incorrect end of the catheter (catheter tip) was connected to the port stem.The catheter tubing, blue boot strain relief, and outlet tube/stem met dimensional specification.No manufacturing non-conformances were observed during sample evaluation.The customer's complaint description of catheter tubing detached at the port body is confirmed.It was observed that the distal tip end of the catheter tubing was attached to the port body.The root cause for this event was determined to be the end user error attaching the incorrect (distal tip) end of the catheter tubing to the port body.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: review of the returned complaint sample identified that the port device may not have been used in accordance with its labeling.The distal tip end of the catheter tubing was connected to the port body.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 disconnection or migration.Catheter embolization.Catheter fragmentation.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.Caution: sufficient slack should be left between the catheter insertion point and the port body to preclude strain on the catheter.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 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: 13544965
• MDR Text Key: 289259398
• Report Number: 1317056-2022-00033
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: CT80STPD
• Device Catalogue Number: CT80STPD
• Device Lot Number: 5660558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 65 KG