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

Catalog Number 10302803

Device Problems Material Integrity Problem (2978); Separation Problem (4043)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2024

Event Type  malfunction  

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 distributor reported an end user experienced an issue when using two (2) bioflo duramax 15.5f 24cm dual valve sheath basic kits.The peelaway introducer, once introduced into the vein, did not peel uniformly as one would expect, but rather partially peeled and broke without being able to peel the sheath to successfully implant the catheter.Another of the same device was opened, and the same thing occurred.Due to the second device failure, the patient suffered serious bleeding from the right jugular vein.It was estimated the patient lost between 600-800ml of blood and required two units of blood to be transfused.After the bleeding was controlled, the catheter placement procedure was completed with a third device from a competitor brand.The patient required several days of hospitalization and is reported to be recovering.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 18920662
• MDR Text Key: 337857885
• Report Number: 1317056-2024-00052
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103028031
• UDI-Public: H965103028031
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10302803
• Device Lot Number: 5744966
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2022
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG