MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER

Catalog Number	46016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1317056-2023-00175
• Device Sequence Number: 15434315
• Product Code: FOZ
• UDI-Device Identifier: H965460161
• UDI-Public: H965460161
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2025
• Device Catalogue Number: 46016
• Device Lot Number: 5805373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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 Sex: Unknown