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

Model Number CT66PTPD

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event 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 perip.Titanium 6.6fr w/ poly cath.Post procedure, the catheter developed a hole.Ultimately, the device was removed and replaced.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

Returned for evaluation was one smartport.As received, the catheter tubing was attached to the port.The customer returned approximately 24cm of catheter tubing.There was a pinch/kink in the catheter from the 4 to 5 cm marks and there was a hole in the catheter at the 5 cm mark.Per catheter tubing drawing, the following dimensions were taken near the distal tip of the catheter and verified using pin gauges and calipers: dimension a (od): sample met specification of 0.085" ± 0.003." dimension b (id): sample met specification of 0.056" ± ).003." the customer's complaint description is confirmed for a hole in the catheter.A definitive root cause could not be determined; however, it was noted that the catheter is thin in the area of the hole.It is unknown if the catheter tubing was thin prior to the hole being formed or if pinching or stretching of the tubing during use caused thinning of the catheter.It was reported that the port was placed in ij and not sub-clavian, therefore, pinch-off syndrome per se is not the likely root cause of the hole in the catheter tubing.Swelling was observed in the clavicle area.When placed in the ij, it is not uncommon to have the catheter tubing transverse over the clavicle, which provides a hard boney support structure.The port/catheter was in situ for more than 29 months.Based on the severe kink/pinch of the catheter tubing and the larger id dimension adjacent to the hole in the catheter tubing, potential root cause for this event is flexural fatigue failure of the tubing in combination with over-pressurization of the catheter lumen.The id/od dimensions of the catheter tubing were confirmed to be within specification near the distal tip of the catheter.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 catalog 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
• 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: 15278755
• MDR Text Key: 305260562
• Report Number: 1317056-2022-00104
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT66PTPD0
• UDI-Public: H787CT66PTPD0
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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: CT66PTPD
• Device Catalogue Number: CT66PTPD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 57 KG