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

Model Number	45753
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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
A territory manager reported an end user experienced an issue when using a mini stick max 4f x 10 cm stiff.018 ni/tu echo 2.75".It was reported that during the procedure, the.035 guidewire punctured through the catheter at the hub causing extravation at the puncture site.This muddied the imaging, making re-access more difficult.A repeat access into the femoral vein was required due to this event.A new of the same device was used for the repeat access.The patient was reported as stable post procedure.
Additional Manufacturer Narrative
Received one (1) coaxial introducer sheath for evaluation.The customer's reported complaint description of the guidewire punctured through the sheath tubing near the hub was confirmed based on evaluation of the returned complaint sample.Inspection of the returned sheath noted a severe kink in the sheath tubing just distal to the junction with the hub.This is also the location of where the guidewire punctured through the side of the sheath tubing.Sheath tubing was likely severely kinked when the physician went to advance the guidewire such that guidewire puncture the wall of the sheath tubing.Root cause is handling damage during use, not quality issue with product.Scar005053 has been initiated due to the reported sheath complaint.The scar005053 and the complaint sample was sent to the coaxial introducer supplier/manufacturer, greatbatch for sample evaluation/root cause determination and dhr review of the reported lots.Scar005053 response stated no manufacturing non-conformance observed during evaluation of the returned complaint sample or dhr review of the production paperwork.Dhr review of the packaging/accessory lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/introducer lots for similar sheath tubing hole/perforated issue.This is the only reported complaint for this sheath tubing hole/perforated failure mode for the mini-stick max product family in the past 15 months, as such, this is deemed to be an isolated incident.Labeling review: direction for use (dfu) (item number 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.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: 21977281
• Report Number: 1317056-2025-00120
• Device Sequence Number: 18460173
• Product Code: DRE
• UDI-Device Identifier: H965457531
• UDI-Public: H965457531
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 5837292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 08/17/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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