MAUDE Adverse Event Report: ANGIODYNAMICS DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER

Catalog Number	H787103012031
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/17/2017
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.(b)(4).
Event or Problem Description
Per user medwatch mw5068034, received on march 10, 2017: patient had a tunneled ij hemodialysis catheter on (b)(6) 2013.The patient was scheduled to have it removed.Upon removal of the catheter, it was noted that the cuff was retained inside the patient.An expert physician was contacted for assistance.She was unable to locate the cuff and it was decided that attempting to locate/remove it would cause more damage than leaving it in.The patient was later discharged with information and instructions related to the retained cuff.The event did not result in prolonged hospitalization or injury to the patient.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.

• Brand Name: DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6463256
• Report Number: 1319211-2016-00037
• Device Sequence Number: 606123
• Product Code: MSD
• UDI-Device Identifier: H787103012031
• UDI-Public: H787103012031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: No Information
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: H787103012031
• Device Lot Number: 566484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 04/06/2017
• 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