MAUDE Adverse Event Report: ANGIODYNAMICS, INC XCELA; PORT & CATHETER, IMPLANTED

Catalog Number	44031
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	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint description of "the needle was unable to be removed from the guidewire during an insertion procedure" was confirmed based on the complaint sample received.The guidewire tip was unraveled/fractured and unable to be removed from the needle.Based on sample evaluation and feedback from end user that the guidewire was pulled back into/against the needle then it can be confirmed the end user did not use the device in accordance with its labeling.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 dfu that is supplied in xcela port plus kits item number {(b)(4)} contains the following precaution: note: if using hydrophilic guidewire, fill the wire holder (hoop) or bathe the guidewire with sterile normal saline for injection to ensure activation of the hydrophilic coating prior to the procedure.This may need to be repeated during the procedure by gently flushing the catheter with sterile normal saline solution for injection through the supplied flush assembly with the guidewire in place.C.Recommended tip location is at or below the axillary line.Precaution: if guidewire must be withdrawn, remove the needle and guidewire as a single unit.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product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).
Event or Problem Description
An angiodynamics territory manager reported an issue with an xcela, 8f single plastic port non-filled non-valved.During a procedure, the.035 guidewire became stuck in the 18 gauge introducer needle and could not be removed.The physician did report pulling the guidewire back through the needle, during the procedure ultimately, the procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.During evaluation of the returned sample, the guidewire was found to be detached, inside of the needle lumen.Follow up determined that the guidewire fracture occurred while placed inside of the needle, in the patient.

• Brand Name: XCELA
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19060625
• Report Number: 1317056-2024-00062
• Device Sequence Number: 5859356
• Product Code: LJT
• UDI-Device Identifier: H965440310
• UDI-Public: H965440310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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 Catalogue Number: 44031
• Device Lot Number: 5810602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 68 KG