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

Catalog Number	H787108007035
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
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: a patient had a schon xl placed that and removed later the next day due to a catheter fracture.The port has been indwelling for 1 day.The catheter was said to have been a pin-hole leak at the y site clear tubing.Upon picking up the catheter to have sent in (returned to the manufacturer) it was noted that the piece was completely removed from the y-site.There was no harm or injury to the patient due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a schon dialysis catheter.The catheter was forwarded to angiodyanmics' vendor for this product for a device evaluation and root cause determination.Per angiodynamics' vendor response, pinholes were noted in venous extension tubing.The most likely root cause for the reported complaint description of pinholes was due to the end user closing a clamp over the catheter while a guidewire was inside of the catheter.The customers reported complaint of a leak in the tube is confirmed.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 this catalog number, 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: 7804413
• Report Number: 1319211-2018-00085
• Device Sequence Number: 11062203
• Product Code: MSD
• UDI-Device Identifier: H787108007035
• UDI-Public: H787108007035
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 04/01/2020
• Device Catalogue Number: H787108007035
• Device Lot Number: MCLK730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1