MAUDE Adverse Event Report: ANGIODYNAMICS, INC. EXODUS; ARRAY MULTIPURPOSE DRAINAGE CATHETER 10F X 25CM WITH STANDARD PIGTAIL

Model Number	10151
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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
An angiodynamics territory manager received notification from an end-user facility that reported a 10f exodus drainage catheter hub crack occurred approximately 1 to 2 days post placement.As a result of the issue, the patient's device was removed and replaced.The patient did not experience any adverse effects or harm as a result of this event.
Additional Manufacturer Narrative
Additional information: returned complaint sample was expected to be a 10f exodus drainage catheter.Received was an 8f exodus drainage catheter.No udi number nor lot number were provided.Reference (b)(4).
Additional Manufacturer Narrative
Received three (3) 8f exodus catheters labeled as (b)(4).As received, the three (3) exodus catheters were all 8f.All three samples were confirmed to have a "crack" in the hub.The customer's reported complaint description of hub cracked was confirmed for the three complaint samples returned per complaint events (b)(4).Likely root cause is handling damage during device use, i.E.Overtightening of male fitting to this hub connection.In addition, prolonged exposure to alcohol cleaning agent on the hub during use is potential contributing factor.Dfu states to avoid use of alcohol with the exodus drainage catheter.A dhr review was not conducted since there was no reported lot number.A dhr review of the ship history report (shr) lots could also not be conducted since the packaged good item number/upn is also unknown.Labeling review: the directions for use (dfu) which is supplied to the end user with this device states: indications for use / intended use exodus array multipurpose drainage catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.G., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses and mediastinal collections.Exodus nuance* nephrostomy drainage catheters are intended for percutaneous drainage of fluid collections in the urinary system.Exodus believe biliary drainage catheters are intended for percutaneous drainage of the biliary tree.Warnings: · do not use catheter for gastrostomy procedures/feeding tube.Exposure to gastric juices may damage the catheter.· do not place catheter into the vascular system.· do not expose this catheter to alcohol, as it may damage the hydrophilic coating and the catheter.Potential complications/adverse events: · catheter break/fracture · catheter dislodgement note: where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.This catheter should be evaluated by the physician on or before 90 days post-placement.Caution: all connections must be secure and airtight.Perform inspections of the catheter and connections regularly.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: EXODUS
• Common Device Name: ARRAY MULTIPURPOSE DRAINAGE CATHETER 10F X 25CM WITH STANDARD PIGTAIL
• 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
• MDR Report Key: 23348290
• Report Number: 1317056-2025-00278
• Device Sequence Number: 8064374
• Product Code: FGE
• UDI-Device Identifier: H965101510
• UDI-Public: H965101510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 10151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 02/25/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/20/2025; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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