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

Model Number	06597052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been 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).
Event or Problem Description
An end user reported an issue with a stf 4f m.I.Kit 45cm nt/t echo s.The customer reported they had a problem with the device.The sheath had been placed and the guidewire inserted.When removing the guidewire and pulling the sheath out of the patient, the sheath shaft detached form the "hub" and was retained inside the patient.The retained portion had to be retrieved.There was no harm to the patient due to this event.
Additional Manufacturer Narrative
The customer's reported complaint description of "the sheath shaft detached form the hub"" was confirmed.The returned complaint sample was noted to have the sheath tubing detached from the hub.The sheath hub and stiffening tube was received advanced on the guidewire where the stiffening tube was still connected to the hub.Device history record (dhr) review of the packaging/accessory lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Scar004997 and the returned sheath/dilator complaint sample were sent to the supplier, greatbatch for sample evaluation/root cause determination and dhr review of the reported lot.Per scar0004997 response, dhr review did not reveal any discrepancies that would have contributed to this event.The sheath hub was sectioned and confirmed that the sheath tubing was correctly inserted and molded to the hub.No manufacturing non-conformance observed during evaluation of the returned device.Sheath tubing broke and the hub junction, likely due to excessive tensile force applied during device use.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 pr(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: 20557603
• Report Number: 1319211-2024-00071
• Device Sequence Number: 13006832
• Product Code: DYB
• UDI-Device Identifier: H787065970520
• UDI-Public: H787065970520
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 06597052
• Device Lot Number: 5826368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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 Sex: Unknown