MAUDE Adverse Event Report: ANGIODYNAMICS ABCCESSION BILIARY DRAINAGE CATHETER

Catalog Number	H787140008025
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	12/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017 via user medwatch 4100120000-2017-8015: (b)(6) yr old white male (b)(6) pounds.The patient had received several injections treatments for recurring lymphocele, this may have contributed to the deterioration of the catheter tip.One of the injections was dehydrated alcohol.During a routine urologic procedure a tiny piece of the tip of a total abscession catheter was noted to be encapsulated in a lymphocele.The foreign body was removed during the routine procedure.The patient was not harmed, no signs of infection were present.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of drainage catheter fracturing in patient cannot be confirmed since no product was returned for evaluation.Without receiving product to evaluate, we are unable to definitively determine root cause for this event.The fractured piece was successfully removed and the patient did not suffer any harm or injury.Although a root cause cannot be definitively determined, it is unlikely that this defect is manufacturing related.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.The instructions for use, which is supplied to the end user with this catalog number, contains a statement; "warnings: do not use this catheter with alcohol.Do not use this catheter as a delivery system for nutritional supplements." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: ABCCESSION BILIARY DRAINAGE CATHETER
• Common Device Name: BILIARY DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6678699
• Report Number: 1319211-2017-00045
• Device Sequence Number: 19415126
• Product Code: FGE
• UDI-Device Identifier: H787140008025
• UDI-Public: H787140008025
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K110936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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 Expiration Date: 09/30/2019
• Device Catalogue Number: H787140008025
• Device Lot Number: 5080321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 06/29/2017
• 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: Required Intervention
• Patient Age: 59 YR