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

Catalog Number	10525
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An angiodynamics territory manager reported that a patient's exodus 8f biliary drainage catheter was observed through imaging to have split into two pieces, right by the pigtail inside of the patient's liver.An additional procedure was performed to remove the catheter tip (requiring additional patient sedation).The device was not replaced as the device was being removed at end of treatment.It was reported the patient was post-op whipple.There was no permanent harm or injury to this patient due to this event.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

• 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 NY 12801
• MDR Report Key: 10702008
• Report Number: 1317056-2020-00300
• Device Sequence Number: 3058640
• Product Code: FGE
• UDI-Device Identifier: H965105251
• UDI-Public: H965105251
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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 Catalogue Number: 10525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR