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

Catalog Number	10800701
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
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 critical care services director reported an issue with a 15cm schon xl doublelumen catheter.Approximately 2 hours after placement, the blue, venous port detached from the device.The device was removed and replaced, with minimal blood loss.The patient did have a delay in starting their hemodialysis sled procedure, but did not experience any adverse effects or harm as a result of this issue.
Additional Manufacturer Narrative
Returned for evaluation was a schon dialysis extension leg (blue hub luer); the remainder of the device was not returned.A visual review of the dialysis catheter shows the extension tube/leg (blue venous side) has a smooth cut and then is jagged.Scar004523, the pictures provided by the customer, and the complaint sample were sent to the schon dialysis catheter manufacturer and design owner, martech medical, to make them aware of this event, request review of dhr for the reported lot number, and a sample evaluation for root cause of extension tubing detachment.Per the scar004523 response: after concluding this research and performing a complete review of the manufacturing process, no potential risk of damage was found and considering that the reported failure mode was replicated and based on the current process controls; 100% leak test and 100% visual inspection.This failure mode is considered not related to the point medical west manufacturing processes.The customer's reported complaint description was confirmed as the extension leg was returned with detachment of the tubing.Although the complaint was confirmed a definitive root cause could not be determined.A possible root cause for the extension leg detaching likely damaged/cut by scalpel and then pulled to failure.A review of the device history records was performed for the indicated lot 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: 13840068
• Report Number: 1319211-2022-00013
• Device Sequence Number: 4731615
• Product Code: MSD
• UDI-Device Identifier: H787108007015
• UDI-Public: H787108007015
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 02/27/2024
• Device Catalogue Number: 10800701
• Device Lot Number: MPVC960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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: 65 YR
• Patient Sex: Male