MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SMARTPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

A field assurance specialist (fas), with becton, dickinson and company (bd),made angiodynamics aware of an angiodynamics 'used defective device" they had received from one of their sales representatives.The fas reported that the port had been implanted at millard fillmore and later removed by great lakes medical imaging.The port had been removed and replaced with a med-comp port due to a hole being discovered in the catheter.Despite multiple good faith effiorts, no further details have been received.

Manufacturer Narrative

The reported defective device has 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

The customer's reported complaint description of hole in the catheter tubing was confirmed.Engineer evaluation: as received, the catheter is trimmed at the 35 cm and assembled.When reviewed the lock was loose on the catheter.The septum appears used.Scratches present on side of port.Deep scratches down the side of the port toward stem and lock.Leak testing revealed holes in the catheter; water spraying from the catheter tubing.Reference engineer attached memo for details.The following picc dimensions were verified per 107482 rev.D: dimension a (od) - sample met specification of 0.085" ± 0.003." dimension b (id) - sample met specification of 0.056" ± 0.003." the following stem dimensions were verified per 107167 rev.B: dimension f (lock bump) - sample met specification of 0.078" ± 0.002." dimension d (od) - sample met specification of 0.050" ± 0.005." the following lock dimensions were verified per 107158 rev.C: dimension c (id) - sample met specification of 0.100" ± 0.002." dimension d (id) - sample met specification of 0.089" ± 0.002." dimension g (id) - sample met specification of 0.100" ± 0.002." the reported complaint description of catheter leaking is confirmed.However, the root cause of the leak is the result of multiple unsuccessful port access attempts (needle puncturing the catheter tubing.The scratches clearly show the access attempts.This resulted in the needle perforating the catheter.A device history record review and ship history report lot review could not be conducted since there was no reported lot number or item number.Labeling review: the instructions for use, which is supplied to the user for smartports, 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: SMARTPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18641420
• MDR Text Key: 334753766
• Report Number: 1317056-2024-00017
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female