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

Catalog Number	10302819
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that 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 or Problem Description
A clinical manager reported an issue with a bioflo duramax 15.5f 28cm dual valve sheath vascpak kit.Approximately 39 minutes into a hemodialysis treatment, a blood leak was discovered.Cracks were discovered in the lumen of the central venous catheter (cvc); therefore, treatment was discontinued and the patient was referred for cvc replacement.The estimated blood loss was less than 30 cc and the patient did not require any hospitalization due to blood loss.The patient did not experience any adverse effects or harm as a result of this incident and had the cvc removed and replaced.The catheter had been in place for approximately 2 years.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of blood leaked due to fracture/crack of extension tubing cannot be confirmed, no sample was returned.  without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.  a potential root cause for this type of failure mode is over torquing of the hub to extension tubing junction during cleaning/use of the device.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 following is provided as a reference from dfu: warnings in the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.Do not use acetone on any part of the catheter tubing.Exposure to this agent may cause catheter damage.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Examine catheter lumen and extensions before and after each treatment for damage.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 DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 15776902
• Report Number: 1317056-2022-00133
• Device Sequence Number: 4923804
• Product Code: MSD
• UDI-Device Identifier: H965103028191
• UDI-Public: H965103028191
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 10302819
• Device Lot Number: 5616718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male