MAUDE Adverse Event Report: ANGIODYNAMICS, INC SCHON XL DOUBLELUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,

Catalog Number	H787108007025
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018.During a dialysis procedure, when the dialysis infusants were administered, the infusants leaked from a hole in the side of the catheter outside of the patient.The device was removed and replaced with a new of the same.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned was a 20cm schon xl dialysis catheter.During a visual/microscopic examination , a hole was observed when a syringe with water was attached, when flushed it was then noted water coming from the hole.The device was forwarded to angiodynamics' supplier of this product for a device evaluation and a root cause determination.The customers reported complaint of a hole in the catheter (extension tube) was confirmed.Although the complaint description is confirmed, a definitive root cause cannot be determined.The most likely root cause for the event is unintended user error.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 states; "clamping the catheter repeatedly in the same spot could weaken the tubing.Change the position of the clamps regularly to prolong the life of the tubing." 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: SCHON XL DOUBLELUMEN CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7734947
• Report Number: 1319211-2018-00075
• Device Sequence Number: 19062697
• Product Code: MSD
• UDI-Device Identifier: H787108007025
• UDI-Public: H787108007025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: H787108007025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1