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	05/28/2023
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
It was reported when replacing the biliary catheter from an exodus drainage cath 8f biliary pigtail std - 35cm kit.At the 90-day replacement procedure, the catheter disintegrated and broke into smaller pieces.All pieces of the catheter were successfully removed.The replacement procedure was completed, using a bsc biliary catheter.
Additional Manufacturer Narrative
The customer's reported complaint description of "the catheter disintegrated and broke into smaller pieces" was confirmed via the provided photo.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Dhr review of the purchased device lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture/distribution.(b)(4) was sent to contract manufacturer freudenberg medical as notification/awareness of this event and dhr review of the reported lot number.The supplier was made aware of this complaint event per (b)(4) and dhr of the reported lot number by freudenberg medical showed no evidence of non-conformances which would reasonably be expected to affect material durability.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.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." 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: 17184933
• Report Number: 1317056-2023-00077
• Device Sequence Number: 12385949
• Product Code: FGE
• UDI-Device Identifier: H965105251
• UDI-Public: H965105251
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: 11/30/2024
• Device Catalogue Number: 10525
• Device Lot Number: 0000196049
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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 Sex: Unknown