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

Catalog Number	10802702
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A physician reported an issue with a 14f x 20cm schon xl double lumen catheter.During a dialysis post procedure on first hemodialysis run, a crack was discovered in the line near the hub.This resulted in air being drawn into the catheter during treatment; however, the air was caught in the air trap; therefore, the patient was unaffected.The patient was already "inpatient" during the initial procedure and the same day, it was reported the device was removed and the patient required a repeat procedure for replacement catheter.The replacement was with the same style schon lumen catheter.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
The customer's reported complaint description cannot be confirmed.No dialysis catheter sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause of this type of device failure mode (hole in extension leg tubing) is handling damage to device during preparation/use, e.G.Closing device clamp when guidewire is still in tubing lumen.Scar004682 was sent to the manufacturer of the schon dialysis catheter device to make them aware of this event and the potential lots affected.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 lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: 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 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: 16232723
• Report Number: 1319211-2023-00002
• Device Sequence Number: 6972368
• Product Code: MSD
• UDI-Device Identifier: H787108027025
• UDI-Public: H787108027025
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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 Catalogue Number: 10802702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG