MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	10303818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned for evaluation was one 15.5f dl 24cm bioflo duramax catheter.As received, the catheter appeared used.The catheter was contaminated with bio matter inside and out.No visual defects were noted to the returned bioflo dialysis.Infusion/aspiration was performed with no difficulties and no air bubbles were noted.The customer's reported complaint description cannot be confirmed.There was no damage or device non-conformance observed during evaluation of the returned sample.A ship history records review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: direction for use {dfu} {angiodynamics item number 16600701-01} bioflo duramax chronic hemodialysis catheter note: the dfu contains a statement.Warning contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping.Precautions examine catheter lumen and extensions before and after each treatment for damage.· to prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments.· use only luer lock (threaded) connectors with this catheter.· excessive force should not be used to flush obstructed lumen.Do not use a smaller syringe than 10 ml.·maintain as wide and gentle a curve as possible to minimize potential for catheter kinking.· for hemodialysis treatment, the national kidney foundation* (disease outcomes quality initiative 2000, guideline 23) guideline indicates a blood flow rate of 300 ml/min to maintain a sufficient extracorporeal blood flow.Strict aseptic technique must be used during insertion, maintenance, and catheter removal procedures.Note: each lumen should be completely filled with heparin to ensure effectiveness.Precaution: extension clamps should only be open for aspiration, flushing, and dialysis treatment.Attach a syringe containing heparin solution to the female luer of each extension.4.Open extension clamps.5.Aspirate to insure that no air will be forced into the patient.6.Inject heparin into each lumen using quick bolus technique.Note: each lumen should be completely filled with heparin to ensure effectiveness.7.Close extension clamps.Precaution: extension clamps should only be open for aspiration, flushing, and dialysis treatment.Insufficient flows: the following may cause insufficient blood flows: · occluded arterial hole due to clotting or fibrin sheath.Solutions include: · chemical intervention utilizing a thrombolytic agent.Management of one-way obstruction: one-way obstructions exist when a lumen can be flushed easily but blood cannot be aspirated.This is usually caused by tip malposition.One of the following adjustments may resolve the obstruction: · reposition catheter.· reposition patient.· have patient cough.· provided there is no resistance, flush the catheter vigorously with sterile normal saline to try to move the tip away from the vessel wall.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.(b)(4).
Event or Problem Description
An end user reported that a patient, with a bioflo duramax catheter, was receiving dialysis treatment when the machine indicated the presence of "microbubbles." the line was running at 310.The nurse was able to resolve the first alarm; however, it occurred again within an hour and more bubbles were visible in the extracorporeal circuit.The caps were changed in hopes to resolve the issue; however, during withdrawing from the red lumen, frothy blood was noted, and the treatment was discontinued.The patient was readmitted to the hospital to have the device removed and a new, different device inserted.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• MDR Report Key: 10316900
• Report Number: 1317056-2020-00119
• Device Sequence Number: 17049798
• Product Code: MSD
• UDI-Device Identifier: H965103038181
• UDI-Public: H965103038181
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: 10303818
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/23/2020
• 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
• Patient Age: 13 YR