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

Catalog Number	H787103035025
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
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 a user medwatch, ref.Mw5083898, received february 26, 2019: patient had malfunctioning permcath placed at another (b)(6) 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.
Additional 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
• Common Device Name: EVENMORE CHRONIC HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8439200
• Report Number: 1319211-2019-00019
• Device Sequence Number: 2015420
• Product Code: MSD
• UDI-Device Identifier: H787103035025
• UDI-Public: H787103035025
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K040402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 04/30/2020
• Device Catalogue Number: H787103035025
• Device Lot Number: 5378460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1