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

Catalog Number	10800703
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A risk manager reported an issue with a 24cm schon xl double lumen catheter.It was reported that the device required replacement due to a hole in the blue port catheter/extension leg.The original catheter was placed and heparinized.Ir did not recognize the leak but it was reported they barely had the catheter un-clamped for any long length of time.Dialysis treatment was started, and a hole was noted during aspiration and flushing, which resulted in a leak in blue port.Ir was notified and the catheter was exchanged.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.
Additional Manufacturer Narrative
Returned for evaluation was one (1) used schon dialysis catheter.The returned sample was placed in water and air was applied to the catheter and the hole was confirmed in the extension leg.(b)(4) and the dialysis catheter complaint sample was sent to supplier/manufacturer (martech) for sample evaluation/root cause determination and dhr review of the reported lot number.  per (b)(4) response, the hole in the extension tubing is consistent with those generated by the clamp when closing it with the guidewire still inside the catheter [extension leg tubing].  the dhr review show no issues of concern.  the customer's reported complaint of a "hole in the blue port catheter/extension leg" was confirmed.The root cause of the hole in the extension leg tubing is likely due to handling damage by end user closing device clamp with guidewire inside of the extension leg tubing.Labeling review: 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 device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lot met all distribution specifications; i.E.No ncr associated with reported failure mode.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SCHON XL DIALYSIS CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15638252
• Report Number: 1319211-2022-00042
• Device Sequence Number: 6518708
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: 06/30/2025
• Device Catalogue Number: 10800703
• Device Lot Number: MQFK520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 63 KG