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

Catalog Number	10522
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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 interventional radiologist reported an issue with an exodus multipurpose drainage catheter 12f 25 cm.The doctor reported having to replace another drain due to our 12f exodus mp drain cracking at the hub.This patient experienced a cracked hub, the day prior (pr (b)(4)).The doctor brought the patient in to place an additional drain and noticed that the current drain was not holding suction.At that time, a crack in the hub was discovered.The patient was an inpatient.It was reported clamps were not used for tightening and chloroprep was used as the cleaning agent.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.The reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported drainage catheter was not returned, angiodynamics is unable to perform a device evaluation.However, the complainant did return 4 unused companion samples.Exodus drainage catheters are a purchased device from supplier/contract manufacturer freudenberg medical.Freudenberg has been notified via scar004275 for sample evaluation and dhr review of supplier lot.As per scar004275 results from freudenberg medical, the unopened samples were evaluated for dimensions and torque.A torque test was conducted on the hub body using the mating component to try to simulate the failure mode.The torque ranged from 16-20 in-lbs with the failure mode of being stripped threads on the luer fitting.There were zero failures for hub cracking.A failure mode cannot be determined.The customer's reported complaint description is confirmed, however the root cause of the event could not be determined.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use which is supplied to the end user with this catalog number states, "warnings: do not use this catheter with alcohol.Placing a 10 french or larger catheter as the primary drain before formation of a tract may be difficult in some patients.In these patients, the initial biliary drainage should be started with a smaller (8 french) catheter until a suitable tract allows placement of a larger catheter.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.".Labeling review: directions for use (dfu) aw1005142-01 states the following: 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.(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 NY 12801
• MDR Report Key: 11429668
• Report Number: 1317056-2021-00061
• Device Sequence Number: 17235558
• Product Code: FGE
• UDI-Device Identifier: H965105221
• UDI-Public: H965105221
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 10522
• Device Lot Number: 0000152287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR