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

Model Number CT80STPD-NFVI

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

The reported 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 end user reported an issue with a smartport ct.During removal of a poorly functioning port, a crack/split in the catheter was discovered.A new port was placed and there was no report of patient harm or adverse event by the end user.It was indicated the reported device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was one port with catheter tubing and blue boot.As received, the catheter and blue boot were attached to the port.The catheter was fractured between the 15cm mark.The catheter was cross sectioned just distal to the slices to be measured.No abnormalities or thin spots were observed.The customer's complaint description of crack/split in the catheter is confirmed.A definitive root cause for this catheter fracture cannot be determined; potential pinch-off syndrome or repeated flexing of catheter at the tunnel-to-vein junction.The catheter is split/fractured in two places at the 15 cm mark.The catheter tubing was confirmed to meet dimensional specifications.No manufacturing non-conformances were observed.The most likely root cause for this failure is repeated flexing of the catheter.Possible contributors are patient anatomy and/or angle of catheter tubing placement into the vein.The repeated flex failure of the catheter fracture is indicative of pinch-off syndrome, however, the fracture location of 3-4cm from the port body is a little close as pinch-off syndrome is typically observed in the catheter tubing between 5-10cm from the port body.Patient anatomy may be a factor in a shorter tunneled section that would make sense for pinch-off.Either way, it is agreed that the fracture of the catheter tubing is due to repeated flex failure over the more than 10 months this port was in situ.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 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 NY 12801
• MDR Report Key: 11429681
• MDR Text Key: 238836610
• Report Number: 1317056-2021-00056
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPDNFVI1
• UDI-Public: H787CT80STPDNFVI1
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2019
• Device Model Number: CT80STPD-NFVI
• Device Catalogue Number: CT80STPDNFVI
• Device Lot Number: 5543961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1