MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS; STIFFENED MICRO INTRODUCER KIT

Model Number	06597051
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 received notification of medwatch (b)(4) regarding a stf 5f m.I.Kit 45cm nt/t echo b.It was reported that during rfv [right femoral vein] temporary pacer placement, mini stick wire knotted and trapped, broke off into rfv.The rn contacted the md on call to come and perform a surgical cutdown to remove the wire.The or team arrived for cutdown and the patient underwent a vascular cutdown for the knotted wire stuck in the groin under local lido and moderate sedation.
Additional Manufacturer Narrative
Correction: d2a.The customer's reported complaint description of guidewire tip detached inside patient cannot be confirmed.No guidewire sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for a guidewire tip detached failure mode is handling damage during use, i.E.The reported knot in the guidewire and/or the end user pulling guidewire back against needle.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.Labeling review: the instructions for use (16650422-01) which is supplied to the end user with this catalog number contains the following statements: intended use: the micro access kit is used for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.Potential complications: · perforation of a vessel or viscus.· laceration of a vessel or viscus.· embolism.Instructions for use: 1.Gain percutaneous access with the 21 gauge needle.2.Advance the 0.018" guidewire through the 21 gauge needle.3.Withdraw the entry needle while leaving the 0.018" guidewire in place.4.Advance the micro-introducer over the 0.018" guidewire.5.Remove the 0.018" guidewire and the micro-introducer inner dilator.6.Advance up to a 0.038" guidewire or catheter through the microintroducer sheath.7.Remove micro-introducer sheath.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: STIFFENED MICRO INTRODUCER KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 8007726446
• MDR Report Key: 22701068
• Report Number: 1319211-2025-00034
• Device Sequence Number: 9037435
• Product Code: DYB
• UDI-Device Identifier: H787065970510
• UDI-Public: H787065970510
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 06597051
• Device Lot Number: 5846810
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White