MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	45753
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
Angiodynamics was notified of an event from the fda, voluntary medwatch mw5172360, regarding a mini stick max 4f x 10 cm stiff.018 ni/tu echo 2.75".It was reported the distal portion of a micropuncture sheath had broken off and remained in the patient's groin during a left heart catheterization.
Additional Manufacturer Narrative
No sheath or dilator product was returned to angiodynamics for evaluation.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.(b)(4) was sent to the coaxial introducer supplier/manufacturer (greatbatch) for awareness of this event.Supplier dhr review of the indicated introducer lots is not required at this time since there has been no previously reported complaints against the lots and potential root cause for sheath tubing detachment is handling damage during use, i.E.Skin nick with scalpel.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications, i.E.No ncr associated with reported failure mode.Review of similar reported complaints against the coaxial sheath has shown a consistent detachment of the sheath tubing at least one (1) cm distal from the sheath hub junction, i.E.Not a failure at the hub junction.The failure of this sheath tubing failure mode generally indicates a slice in the tubing from a sharp object with separation location of the tubing being stretched, indicating a tensile failure of the tubing.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.Labeling review: directions for use (dfu) that is provided with this device contains the following statements.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: ANGIODYNAMICS
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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 ; 8007726446
• MDR Report Key: 22701066
• Report Number: 1317056-2025-00203
• Device Sequence Number: 21091764
• Product Code: DRE
• UDI-Device Identifier: H965457531
• UDI-Public: H965457531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2025

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 Model Number: 45753
• Device Lot Number: 5843957
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White