MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER

Catalog Number 46016

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The 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

A territory manager reported an end user experienced an issue when using a guidewire from a bioflo midline 4f sl-20cm max barrier drape kit.After placing the guidewire, the wire unwound and frayed at the tip, and a 5mm piece actually broke off in the patient's soft tissue.A new tray was set up in order to continue to place the midline, at which time the guidewire was accidentally disposed of with the used kit.The new midline was placed in the patient's other arm.They reported that only a small piece of the tip had fractured off, approximately 5mm x 0.5mm according to the follow up imaging, so it was decided by the doctor that it posed the patient no risk and was left in the soft tissue.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description guidewire unraveled during use was not confirmed due to the sample wasn't returned for evaluation.Without receiving the complaint sample for evaluation, we are unable to definitively determine a root cause for this incident.The guidewire device is supplied to angiodynamics by the supplier/manufacturer heraeus medical.Scar 004855 was sent to heraeus for dhrr of this reported event.Device history record review of the packaging/guidewire lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A potential root cause for this type of guidewire unraveled within vasculature failure mode is end user technique in pulling guidewire back against the needle tip bevel.This is cautioned against in device directions for use.Labeling review: the dfu that is supplied in bioflo kits item number (14600281-01) contains the following precaution: note: if using hydrophilic guidewire, fill the wire holder (hoop) or bathe the guidewire with sterile normal saline for injection to ensure activation of the hydrophilic coating prior to the procedure.This may need to be repeated during the procedure by gently flushing the catheter with sterile normal saline solution for injection through the supplied flush assembly with the guidewire in place.Recommended tip location is at or below the axillary line.Precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit.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 MIDLINE
• Type of Device: MIDLINE CATHETER
• 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: 18358300
• MDR Text Key: 330902791
• Report Number: 1317056-2023-00175
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: H965460161
• UDI-Public: H965460161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 46016
• Device Lot Number: 5805373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2023
• 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