MAUDE Adverse Event Report: ANGIODYNAMICS EVENMORE CHRONIC HEMODIALYSIS CATHETER

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and is not available to be returned to the mfr for eval.An investigation into the root cause of this incident is currently in progress.The results of the device eval will be sent via a f/u medwatch.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 specs.(b)(4).

Event Description

As reported on (b)(6) 2015, a pt of unk age and gender presented for a dialysis procedure in (b)(6) 2015.The procedure was successfully completed with no complications or device malfunction.Approx 30 days later, in (b)(6) 2015, it was reported the pt was experiencing an infection at the insertion site.It was determined that when the device was implanted, the treating physician had failed to remove the sheath.The sheath was removed from the pt at that time.The pt was successfully treated for the infection and reported as doing well.The device is not available for return to the mfr for eval as it was disposed of by the user.

Manufacturer Narrative

As the reported complaint sample was disposed of by the user and not returned, angiodynamics is unable to perform a device evaluation.However, based on information provided, the customer's reported complaint description of the patient experiencing an infection at the insertion site is confirmed.The root cause of the infection is most likely due to the sheath left implanted at the insertion site.The sheath would have most likely been observed with proper wound care techniques described in the ifu.Follow up information indicates that the patient is stable and suffered no permanent harm or injury.The instructions for use, which is supplied to the end user with this catalog number states; "caution: never leave sheath in place as an indwelling catheter.Damage to the vein will occur." also stated is, "clean skin around catheter.Cover the exit site with occlusive dressing and leave extensions, clamps, and caps exposed for access by staff.Wound dressings must be kept clean and dry.Suture insertion site closed.Suture the catheter to the skin using the suture wing.Do not suture the catheter tubing.Caution: care must be taken when using sharp objects or needles in close proximity to catheter lumen.Contact from sharp objects may cause catheter failure.Cover the insertion and exit site with an occlusive dressing.Catheter must be secured/sutured for entire duration of implantation".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.(b)(4).The follow up mdr for this complaint record was originally submitted on 02/17/2016 via usps.Due to e-submitting requirements, it was returned for resubmitting.

• Brand Name: EVENMORE CHRONIC HEMODIALYSIS CATHETER
• Type of Device: CHRONIC HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5337953
• MDR Text Key: 34912944
• Report Number: 1319211-2015-00387
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/27/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention