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

Catalog Number	10541
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
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.(b)(4).
Event or Problem Description
A radiology technician reported an issue with an indwelling exodus multipurpose 14f 25 cm drainage catheter.It was reported that a crack was discovered in the hub.The catheter was removed and replaced with another same device.The patient did not experience any adverse effects or harm as a result of this incident.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an exodus drainage catheter.As received, the drainage catheter hub was cracked.The drainage catheter was contained with bio material inside and out.Exodus drainage catheters are a purchased device from supplier/contract manufacturer freudenberg medical.Freudenberg has been notified via scar004263 for sample evaluation and dhr review of supplier lot.As per scar004263 results from freudenberg medical, visual review confirmed that the hub body was cracked for thereturned sample.A failure mode cannot be determined.A review has indicated that there are no issues with the molding process or the assembly process.These processes do not expose the hub to chemicals which could indue the crack.The device was manufactured in accordance with the dmr.This complaint is not manufacturing attributable.No correction is required as freudenberg medical did not attribute the hub crack to be manufacturing related; root cause cannot be determined.The customer's reported complaint description is confirmed, however the rott 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.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 NY 12801
• MDR Report Key: 11256408
• Report Number: 1317056-2021-00024
• Device Sequence Number: 1284217
• Product Code: FGE
• UDI-Device Identifier: H965105411
• UDI-Public: H965105411
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• 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: 03/31/2023
• Device Catalogue Number: 10541
• Device Lot Number: 0000146598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 01/31/2021
• 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