MAUDE Adverse Event Report: ANGIODYNAMICS TOTAL ABSCESSION; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	14000823
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable 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
An end user reported an issue with a total abscession drainage catheter gen 8f x 30cm without r/o band.The catheter was used during a ct-guided cyst drainage and sclerotherapy.When the catheter was being removed from patient, the tech noted that the tip of the catheter was missing.A ct of pelvis confirmed presence of retained tip in the endometrioma.There was an attempt to remove the tip with a percutaneous procedure, but was unsuccessful due to it being embedded in the tissue.
Additional Manufacturer Narrative
No total abscession drainage catheter product was returned to angiodynamics for evaluation.It is unknown how long the drainage catheter was in situ.Per dfu, "it is recommended that indwelling time not exceed 90 days".The customer's reported complaint description of total abscession drainage catheter tip detached could not be confirmed since no complaint sample was returned.Without receiving product for evaluation a definitive root cause could not be determined.Potential root cause is exposure of the catheter to alcohol.As noted in the device dfu (14600186-01) "warnings: do not use this catheter with alcohol.".Another potential root cause of the catheter tubing fracture and detachment is break down of the catheter material due to chemical exposure from either flushing agents or the abscess fluid.Dhr review of the packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.This is the only reported complaint for this catheter tip detached failure mode for the total abscession product family in the past 15 months, as such, it is deemed to be an isolated incident.Labeling review: the instructions for use (14600186-01) which is supplied to the end user with this catalog number states, "to tighten the pigtail shape, gently pull the suture until resistance is felt.Warnings: do not use this catheter with alcohol.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." 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).Correction: d4, model number, unique primary device identifier, e4 changed from unknown to yes.

• Brand Name: TOTAL ABSCESSION
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21631464
• Report Number: 1319211-2025-00011
• Device Sequence Number: 9309222
• Product Code: FGE
• UDI-Device Identifier: H787140008235
• UDI-Public: H787140008235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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 Model Number: 14000823
• Device Lot Number: 5815882
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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 Age: 39 YR
• Patient Sex: Unknown