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

Catalog Number	45750
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	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has not yet been returned to the manufacturer, despite multiple attempts to obtain the sample.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 territory manager reported that the dilator, from a mini stick max 4f x 10 cm std.018 ni/tu echo 2.75" pg broke off, inside of the patient.The fragment was able to be removed, via snare and the remaining procedure was completed with another same device.The patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
The customer's reported complaint description of the sheath tubing broke off inside of the patient cannot be confirmed since no 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.The mini stick coaxial introducer is contract manufactured for angiodynamics by medron.(b)(6) was sent to medron for awareness of this event and dhr review of the supplier lots.(b)(6) response states, no samples or photos were returned, therefore, the direct cause of this issue cannot be investigated fully.The dhr review did not identify any discrepancies with the manufacturing of the parts.No manufacturing defect can be confirmed based on this information.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 COAXIAL MICROINTRODUCER KIT
• Common Device Name: DILATOR, VESSEL
• 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: 19036693
• Report Number: 1317056-2024-00058
• Device Sequence Number: 6992314
• Product Code: DRE
• UDI-Device Identifier: H965457501
• UDI-Public: H965457501
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/21/2024

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: 45750
• Device Lot Number: 5811505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male