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	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An angiodynamics territory manager reported an issue with a 15cm schon xl double lumen catheter.It was reported that the venous lumen detached from the catheter, while implanted in the patient.The patient damaged the catheter while she was in her room causing the patient to loose blood.When the ir pa went to bedside, the hospitalist and 4 nurses were helping the patient.They used a hemostat to stop the gushing blood.The catheter was removed and replaced and the patient did not require any medical intervention as a result of the blood loss.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a schon dialysis catheter in two pieces.A visual review of the dialysis catheter shows that one extension tube/leg (blue venous side) was detached from the bifurcation hub.It is noted that the extension tubing break point is inside the bifurcation hub molding, i.E.There is some portion of the extension tubing inside the bifurcation hub.(b)(4), the pictures provided by the customer and the complaint sample have been sent to 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 sample evaluation for root cause of extension tubing detachment.Per (b)(4) response, martech re-trained personnel in the current revision of the manufacturing procedure for cutting silicone tubing to length using a versa cutter in case this was a contributing factor (this action is completed).In addition, a 100% sort will be held for a period of 3 months to evaluate the tubing cutting process and define if it's necessary implement any improvement that leads us to eliminate this problem or was a unique/isolated incident.The customer's reported complaint description was confirmed as the catheter returned was noted to have one extension leg detached.Although the complaint was confirmed a definitive root cause could not be determined.A possible root cause for the extension leg detaching could be due to a significant pull force to failure during use.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.(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: 12477031
• Report Number: 1319211-2021-00063
• Device Sequence Number: 4030391
• Product Code: MSD
• UDI-Device Identifier: H787108007015
• UDI-Public: H787108007015
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 05/22/2023
• Device Catalogue Number: 10800701
• Device Lot Number: MPMN270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female