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

Model Number CT80STPD

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported: a patient with an indwelling smartport.Treating physician determined the ct80 smartport was not functioning.He had placed the port originally on (b)(6) 2019 and replaced it with another ct80.There was no report of patient harm or injury due to this event.It was reported the defective disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a smartport with catheter tubing.Visual/microscopic exam: as received, catheter tubing and blue boot were attached to the port.The customer only returned the 20cm of catheter tubing.There is a slice/hole in the catheter tubing at the 12cm mark; approximately 5-6cm from the port.Bio material was noted to the inside of catheter tubing and port septum.The reported complaint description is confirmed.The root cause of the event was determined to be due to the fracture of the catheter tubing.A root cause for the catheter tubing fracture cannot be definitively determined, however, based on the location of the fracture from the port body (5-6cm) and the longitudunal slice of the fracture, potential root cause of the fracture is pinching/crushing of the tubing from pinch-off syndrome.This cannot be confirmed as it was not reported if the port was placed sub-clavian or via the ij.Over-pressurization of the catheter tubing may have also been a contributing factor as this is indicative of longitudunal slices in a catheter tubing a review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use, which is supplied to the user with this catalog number, contains the following statements: 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: use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: these complications are well documented in literature and should be considered when a venous access device is utilized.Catheter disconnection or migration.Catheter embolization.Catheter fragmentation.Migration.Right arterial puncture.Precautions: to avert device damage and/or patient injury during catheter placement: avoid accidental device contact with sharp instrument and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.Do not use the catheter if there is any evidence of mechanical damage or leaking.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).Carefully follow the connection technique given in these instructions to insure proper catheter connection and to avoid catheter damage.Assure tight connection between port chamber and catheter.Implantation of attachable catheter: trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.Warnings: maximum pressure recommended for power injection of contrast media with the smart port ct implantable ports is 300 psi and a maximum flow rate of 5ml/sec.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.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: SMART PORT
• Type of Device: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• MDR Report Key: 9805809
• MDR Text Key: 198789685
• Report Number: 1317056-2020-00050
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2020

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: 03/31/2022
• Device Model Number: CT80STPD
• Device Catalogue Number: H787CT80STPD0
• Device Lot Number: 5451426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1