MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS; INTRODUCER, CATHETER

Model Number	06597034
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with an std 4f m.I.Kit 45cm nt/t non-echo s.It was reported that the introducer broke during insertion, resulting in a foreign body within the patient.Ultimately, the foreign body was removed successfully, in an open cut-down procedure, and the patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
The reported device is anticipated to be returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of the sheath tubing detached from the hub was confirmed.The returned complaint sample was noted to have the sheath tubing detached from the hub, based on length specification (no hub was returned).A device history record (dhr) review of the packaging/accessory lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.(b)(4) and the returned sheath tubing complaint sample was sent to the supplier, greatbatch, for sample evaluation/root cause determination and dhr review of the reported lot.Per (b)(4) response, dhr review did not reveal any discrepancies that would have contributed to this event.The sheath tubing was confirmed to meet length specification and no manufacturing non-conformance was observed.Root cause of sheath tubing detached from hub could not be determined.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 micro introducer 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: INTRODUCER, CATHETER
• 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 ; 5086587990
• MDR Report Key: 20903386
• Report Number: 1319211-2024-00073
• Device Sequence Number: 12999038
• Product Code: DYB
• UDI-Device Identifier: H787065970340
• UDI-Public: H787065970340
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Expiration Date: 06/30/2025
• Device Model Number: 06597034
• Device Lot Number: 5739965
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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: 67 YR
• Patient Sex: Male