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

Catalog Number	10800702
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	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Ir placed a 14fx20cm schon xl double lumen dialysis catheter for hemodialysis.During use, the nurse noticed alarms for air on the venous line.The setup was changed, and the procedure was attempted to be restarted again, however the venous line port tubing had a small hole about 1" from the port with blood dripping out.The nurse stopped the treatment and replaced the catheter.The treatment was able to be continued with no further complications.The patient did not experience any adverse effects or harm due to this incident.
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.(b)(4).
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 (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.Scar004731 was sent to the manufacturer of the schon dialysis catheter device to make them aware of this event and the potential lot affected.As mentioned in scar004731 response, "as well it was found during previous investigations that to mitigate the risk of damaging the extension by clamping with the stylet still placed into the catheter a tag with the statement "attention: do not clamp over stylet" is being placed in the blue clamp (vein side) during the kit construction." could be a possible root cause for the complaint description.Device history record review of the packaging lot revealed no quality related issue during distribution of the device.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 ; 5086587990
• MDR Report Key: 16743232
• Report Number: 1319211-2023-00022
• Device Sequence Number: 5378442
• Product Code: MSD
• UDI-Device Identifier: H787108007025
• UDI-Public: H787108007025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: 10800702
• Device Lot Number: MPHV390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 74 KG