MAUDE Adverse Event Report: ANGIODYNAMICS EXODUS DRAINAGE CATHETER; BILIARY (GENERAL) (NEPHOSTROMY) DRAINAGE CATHETER

Catalog Number	10526
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
The biliary drainage catheter, 10f 35 cm std loop w/ radiopaque marker band drain was in patient less then 90 days, when it fractured in the patient.They had to perform a foreign body procedure to get the remaining drain material.The drain was replaced with a new of the same device.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation, however an xray omage was provided.The customer's reported complaint description of catheter tip detached was confirmed via review of x-ray image provided.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential contributing factor for biliary drainage catheter tip detachment is patient chemistry since tip is intended to be placed in the duodenum, which is a caustic environment.In addition, it is unknown if the patient's gi tract was altered due to trauma or surgery, which can affect location of the drainage catheter tip.Catheter break/fracture is listed as potential complication in the device dfu dhr review of the packaging lots revealed no quality related issues or manufacturing deficiencies at the time of distribution.(b)(4) was sent to contract manufacturer freudenberg medical as notification/awareness of this event and dhr review of the reported lot number.No issues observed during device assembly inspection labeling review: the directions for use 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 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.Note: for the exodus believe biliary drainage catheter, the distal tip of the catheter is advanced as far as the duodenum with the radiopaque marker in the biliary tree.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 DRAINAGE CATHETER
• Common Device Name: BILIARY (GENERAL) (NEPHOSTROMY) DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16833150
• Report Number: 1317056-2023-00056
• Device Sequence Number: 1842330
• Product Code: FGE
• UDI-Device Identifier: H965105261
• UDI-Public: H965105261
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 10526
• Device Lot Number: 0000 223553
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown