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

Model Number CT75STSD

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2022

Event Type  Injury  

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).

Event Description

A director of clinical services reported an issue with a single titanium ct vtx port.During a placement procedure, the catheter had a material break from the port (it did not detach from the port) within the patient's brachiocephalic vein; the catheter retracted into the vein and migrated in the superior vena cava.The patient was immediately transferred from the operating room, via emergency vehicle, to covenant medical center where they were taken to interventional radiology.The catheter remnant was removed from the patient and a new port was placed.The patient was discharged from the hospital on the same day.

Manufacturer Narrative

Returned for evaluation was one(1) piece of catheter tubing.As received, the customer returned approximately 22cm of catheter tubing for evaluation.During the cleansing process, the catheter was occluded with bio material {blood clots}.The customer's reported complaint description of catheter tubing fractured and detached was confirmed.Tubing id and od dimensions were measured and observed to be within specification.Given that the returned catheter fractured at the 22.5cm marking location this fracture site is likely to have been close to the port body.No catheter tubing non-conformances observed (visual/dimensions) and review of incoming inspection data sheet showed tensile force for catheter tubing was well above specification.A definitive root cause for the event cannot be determined.A potential root cause of catheter tubing fracture and detachment is handling damage during use, i.E.Excessive tensile force applied.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 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.Implantation of attachable catheter: - insert catheter into sheath.Position the distal end of the catheter at the desired location.Peel away sheath while withdrawing it from vessel.Care should be taken not to withdraw catheter as sheath is removed.Catheter position should be confirmed radiographically.Secure catheter in place.- trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.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
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16068906
• MDR Text Key: 306344373
• Report Number: 1317056-2022-00151
• Device Sequence Number: 1
• Product Code: LJT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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 Model Number: CT75STSD
• Device Catalogue Number: CT75STSD
• Device Lot Number: 5753716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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: 62 KG