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

Catalog Number	LPS5013
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	01/14/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
On or about (b)(6) 2009, (b)(6) underwent placement of an angiodynamics lifeport product, catalog no.: lps5013, lot number 941892.Upon information and belief, the device was implanted by dr.(b)(6), m.D., at (b)(6) hospital, in (b)(6) california, for chemotherapy treatment for plaintiff's breast cancer.Upon information and belief, in (b)(6) 2009, plaintiff presented to (b)(6) hospital in (b)(6) california, to be evaluated for irregular heart rate.The plaintiff's medical team determined at that time that she needed to be admitted overnight.On or about (b)(6) 2010, the plaintiff returned to (b)(6) hospital.After further review of the imaging, it was determined that defective port was thrombosed and that it fractured, and that the fractured piece migrated into her right atrium.Upon information and belief, the fractured and thrombosed port (namely the lifeport reservoir and the parts of the dislodged catheter) was then removed by dr.(b)(6) m.D., at the same facility.As a result of having the lifeport implanted, the plaintiff has, allegedly, experienced significant pain and suffering, has undergone additional surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.
Additional Manufacturer Narrative
The reported device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for this event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of catheter tubing fractured and detached cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential root cause for the reported catheter fracture and detachment failure mode is pinch-off syndrome, which is cautioned in the device dfu.Device history record (dhr) review of the indicated packaging/assembly/component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no previously reported complaints for the indicated packaging/assembly/component lots for similar catheter detached issues.The catheter and locking collar are provided as a separate components within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with locking collar) during the implantation procedure.Labeling review: the instructions for use, (16605362-01) which is supplied to the user with this catalog number, contains the following statements.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.After implantation and during system use each access to the vortex® mp port system should be performed using aseptic technique.Use only non-coring needles with the vortex® mp port system.The noncoring needle design helps maintain the self-sealing septum.Under qualified procedures the vortex® mp port system allows up to 2,000 punctures with an angiodynamics® 22 gauge noncoring needle, when tested at 10 psi.This pressure exceeds the typical levels experienced in clinical practice.· do not use a syringe smaller than 10 ml.Smaller syringes may create an over-pressurized condition in the system.Warning: for chest placement, avoid medial catheter placement instructions for implantation of the vortex® mp port 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 to the subclavian vein.Note: a port placed too deeply may be difficult to palpate and access.Potential complications use of the system involves potential risks associated with any implanted device or indwelling catheter.They include, but are not limited to: catheter fragmentation catheter pinch-off embolization 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: LIFEPORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls 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: 20358725
• Report Number: 1317056-2024-00162
• Device Sequence Number: 20654120
• Product Code: LJT
• UDI-Device Identifier: H787LPS50130
• UDI-Public: H787LPS50130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K905839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: LPS5013
• Device Lot Number: 941892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female