MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PORT; PORT & CATHETER

Model Number 44014

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Bacterial Infection (1735); Erosion (1750); Chest Pain (1776); Unspecified Infection (1930); Infiltration into Tissue (1931); Pain (1994); Perforation (2001); Pneumothorax (2012); Skin Erosion (2075); Post Operative Wound Infection (2446); Decreased Respiratory Rate (2485); Tissue Breakdown (2681); Fluid Discharge (2686); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190); No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

On (b)(6) 2018, the patient presented for subclavian placement of a bioflo port port for administration of chemotherapy for breast cancer.Following the implantation, the patient began to experience discomfort on the upper right anterior chest, neck,and axillae.On (b)(6) 2018, the port site was assessed and serosanguinous fluid was found medial to the port reservoir, with no signs of infection.The following month ((b)(6) 2018), the patient underwent a procedure to remove the defective device.Upon incision of the port site, cloudy serosanguineous fluid immediately well up and poured through the open incision.Allegedly due to leakage of the chemotherapy medication, the pocket was noted to contain "adherent black and brown soft tissue debris, some of which appeared to represent old blood clot and necrotic tissue." the surgeon debrided the necrotic tissue until the pocked appeared well-vascularized and viable.A week later ((b)(6) 2018), a new bioflo picc with 4fr single lumen catheter, was placed.The following week after placement ((b)(6) 2018), the patient presented to the hospital with occlusive deep venous thrombosis, within the left upper extremity and acute pulmonary embolism.At this time, the patient was started on lovenox and was later switched to angiomax after the developed heparin-induced thrombocytopenia.There was no permanent harm or injury to the patient due to this event.The reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of "catheter tip fractured/migrated" is not confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.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 (16608102-01) which is supplied to the user with this catalog number, contains the following statements: contraindications: catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Procedure for power injection.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.Potential complications: catheter fragmentation catheter embolization 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 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: BIOFLO PORT
• Type of Device: PORT & CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11116792
• MDR Text Key: 225076283
• Report Number: 1317056-2021-00003
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H965440140
• UDI-Public: H965440140
• Combination Product (y/n): N
• PMA/PMN Number: K131694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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 Expiration Date: 07/31/2021
• Device Model Number: 44014
• Device Catalogue Number: 44014
• Device Lot Number: 5371479
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other