MAUDE Adverse Event Report: ANGIODYNAMICS, INC MINI STICK MAX; VESSEL DILATOR

Catalog Number	45759
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is not available to be returned to the manufacturer, for evaluation, due to disposal.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An angiodynamics regional business manager reported an issue with a mini stick max 5f x 10 cm stiff.018 ni/tu echo 2.75" pg.During removal, the device "came apart" when removing from the patient's body.It was reported that it looks as if the sheath portion ( 0.035 10cm white part) is no longer attached to the hub.There was no report of patient harm or adverse event by the end user.
Additional Manufacturer Narrative
The customer's reported complaint description of sheath tubing detached cannot be confirmed.No sheath complaint sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Device history record review of the packaging/introducer lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Potential root cause for this type of failure mode is tubing being nicked by sharp object (e.G.Scalpel) and then pulled to failure resulting in distal end of tubing migrating into the vasculature.Scar004933 was sent to sheath/dilator supplier/manufacturer, greatbatch for awareness and dhr review of supplier lot numbers.Greatbatch confirmed no internal non-conformance reports were found regarding batch in question.This event cannot be confirmed to be a manufacturing issue.Labeling review: direction for use (dfu, 16600601-01) is provided with this mini stick device.The failure mode of device fracture and embolization is cautioned as potential adverse event.No sample was returned for evaluation so it cannot be determined if device was used in a manner inconsistent with labeling.Intended use/ indications for use: the coaxial micro introducer kit is used for the percutaneous introduction of a guidewire into the vascular system.Adverse events: guidewire shearing, fracture or embolization.Operational instructions 1.Prior to insertion, flush all components with saline or heparinized/saline.2.Gain percutaneous access with the 21 g (0.9 mm) vascular introducer needle.3.Advance the 0.018 inch (0.46 mm) guidewire through the needle.Caution: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire.4.Withdraw the introducer needle, leaving the 0.018 inch (0.46 mm) guidewire in place.5.Advance the coaxial assembly over the 0.018 inch (0.46 mm) guidewire.6.Simultaneously remove the dilator and 0.018 inch (0.46 mm) guidewire, while holding the sheath portion of the assembly in place.7.Advance a 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) guidewire into the sheath.8.Remove the sheath, leaving the 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) wire.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: MINI STICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19072505
• Report Number: 1317056-2024-00063
• Device Sequence Number: 6826096
• Product Code: DRE
• UDI-Device Identifier: H965457591
• UDI-Public: H965457591
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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 Catalogue Number: 45759
• Device Lot Number: 5813624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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