MAUDE Adverse Event Report: ANGIODYNAMICS, INC EVENMORE CHRONIC HEMODIALYSIS CATHETER

Catalog Number H787103035025

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2019

Event Type  malfunction  

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 investigation will be sent via a follow up medwatch.(b)(4).

Event Description

Per a user medwatch, ref.Mw5083897: patient had malfunctioning permcath placed at another (b)(6) care facility.Hole noted near the red hub.Permcath replaced in operating room.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customers reported complaint of a hole in the catheter (extension tube) cannot be confirmed as a device evaluation was not performed.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.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.Prior to packaging the product, the devices visually inspected to ensure it is not kinked.The instructions for use, which is supplied to the end user with states; "catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Examine catheter lumen and extensions before and after each treatment for damage.In the event a clamp breaks, replace the catheter at the earliest opportunity.Irrigate catheter with saline, then clamp catheter extensions to assure that saline is not inadvertently drained from lumens.Use clamps provided.Caution: do not clamp the dual lumen portion of the catheter.Clamp only the extensions.Do not use serrated forceps, use only the in-line clamps provided.Caution: extension clamps should only be open for aspiration, flushing, and dialysis treatment." 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: EVENMORE CHRONIC HEMODIALYSIS CATHETER
• Type of Device: EVENMORE CHRONIC HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8591266
• MDR Text Key: 145639541
• Report Number: 1319211-2019-00044
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787103035025
• UDI-Public: H787103035025
• Combination Product (y/n): N
• PMA/PMN Number: K040402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H787103035025
• Device Lot Number: 5412497
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Patient Sequence Number: 1