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

Model Number	45749
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a mini stick max 4f x 10 cm std.018 ss/tu echo 2.75.During an angiographic procedure, a ministick max was used for access to right femoral artery.It was reported that most of the exterior catheter split into the patient.Doctor [name redacted] was called to perform a cut down and to remove the fragment.The patient was intubated and sent to icu.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and 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).
Additional Manufacturer Narrative
Correction: d2a.The customer's reported complaint description of sheath tubing detached was confirmed based on evaluation of the returned complaint sample.The sheath tubing was observed to be detached from the sheath hub and the middle section of sheath tubing was fractured/detached.The mini stick max is a coaxial micro-introducer kit used for initial access into the vasculature.Once the coaxial sheath is in place an 0.035/0.038" procedure (j) guidewire is inserted into the vasculature.Depending on the purpose of the patient procedure the sheath may be upsized (e.G.7f, then 10f, then 14f, etc.) to accommodate larger french size catheters/devices.After inserting the 0.035" guidewire into the coaxial sheath but prior to removal of the coaxial sheath the physician may choose to nick the skin with a scalpel at the insertion site in anticipation of the insertion of the larger sheath device.This technique may cut the coaxial sheath tubing such that the tubing is pulled to failure during removal of the coaxial sheath.If a nick of the skin is required then performing this after the coaxial sheath is removed (i.E.Nick skin with just 0.035" guidewire sticking out of insertion site) would prevent damage to sheath tubing and potential tubing tensile failure.Handling damage during device use is likely root cause for sheath tubing detachment.Scar005098 and the returned sheath/dilator complaint sample was sent to the sheath/dilator supplier/manufacturer (greatbatch) for sample evaluation/root cause determination and dhr review of the reported lots.Scar005098 response states that after evaluation of the complaint sample, no supplier mfg non-conformance was observed, which included dhr review of the reported lots.A dhr review of the packaging/introducer lots revealed no quality related issues or mfg deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/introducer lots for similar sheath/dilator tubing detached issues.Labeling review: directions for use (dfu) that is provided with this device contains the following statements.The failure mode of device 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: ANGIODYNAMICS
• Common Device Name: MINI STICK MAX COAXIAL MICROINTRODUCER KIT
• 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 ; 8007726446
• MDR Report Key: 22942746
• Report Number: 1317056-2025-00207
• Device Sequence Number: 9755402
• Product Code: DRE
• UDI-Device Identifier: H965457490
• UDI-Public: H965457490
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45749
• Device Lot Number: 5841413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White