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

Catalog Number	10802702
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
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
It was reported that the patient was on crrt.Lines reversed.Rij hd cath.The crrt machine began to alarm "foam detected" and it stopped.The provider assessed the lines and air was noted throughout the system.When evaluating the schon catheter connections to lines everything appeared intact, however, upon further inspection the access line (red line) was connected to blue port of catheter and the connection was slightly loose.There was no noted blood leaking around connection, but was noted to be the site of the air entering the system.The device was removed and replaced the next day.There was no report of the patient experiencing any adverse effects or harm as a result 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.Potential root cause of this type of device failure mode (air bubbles in device) is hole in extension leg tubing due to handling damage during device preparation/use, e.G.Closing device clamp when guidewire is still in tubing lumen.Scar004694 was sent to the manufacturer of the schon dialysis catheter device to make them aware of this event and the potential lots affected.Labeling review: the instructions for use, which is supplied to the end user with states; "it is recommended that only luer lock (threaded) connections be used with this catheter (including syringes, bloodlines, iv tubing and injection caps).Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure.Inspect the catheter frequently for nicks, scrapes, cuts, etc.Which could impair it performance." 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.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: 16303203
• Report Number: 1319211-2023-00005
• Device Sequence Number: 7048898
• 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: 2023
• 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
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 29 KG