MAUDE Adverse Event Report: ANGIODYNAMICS DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	10302818
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Air Embolism (1697); Foreign Body In Patient (2687)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
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
An ir supervisor reported an issue with a 24cm duramax dialysis catheter.During a placement procedure, the introducer sheath broke in half when the pa was attempting to peel the sheath away.This occurred while a portion of the catheter was inside of the patient.The catheter was removed with the broken introducer sheath and a new introducer sheath was used with the same catheter to complete the procedure.Post-procedure, immediately following insertion of the catheter, the patient suffered a stroke; therefore, the hospital stroke team was activated and the patient was sent to ct for imaging.The cause of the stroke was found to be an air embolism and the patient was transferred to another hospital for treatment in a bariatric chamber.The latest update the team received stated that the patient is in stable condition and the stroke is believed to be a direct result of the product malfunction.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of "the introducer sheath broke in half when the pa was attempting to peel the sheath away", could not be confirmed as a sample was not returned for evaluation.A definitive root cause cannot be determined without a sample being returned for evaluation.Scar004546 was sent to the supplier/manufacturer (merit medical) of this sheath/dilator accessory device as awareness of this event and to perform a review of the dhr for the reported lot.No issues were observed during dhr review of the supplier lot.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: dilators and catheters should be removed slowly from the sheath.Rapid removal may damage the valve members resulting in blood flow through the valve.Never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.Insert vessel dilator into sheath until the dilator cap folds over valve housing and secures the dilator onto sheath assembly.Thread the dilator/sheath assembly over the guide wire.Advance the dilator and sheath together with a twisting motion over the guide wire and into the vessel.Fluoroscopic observation may be advisable.Attaching a clamp or hemostat to the proximal end of the guide wire will prevent inadvertently advancing the guide wire entirely into the patient.Once assembly is fully introduced into the venous system, separate the dilator cap from the sheath valve housing by rocking the dilator cap off the hub.Slowly retract the guide wire and dilator, leaving the sheath in position.The hemostasis valve will reduce the loss of blood and the inadvertent aspiration of air through the sheath.Introduce catheter through the hemostasis valve/sheath and advance it into position.Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel sheath apart while withdrawing from the vessel.Potential complications: air embolus 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: DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 14315089
• Report Number: 1319211-2022-00019
• Device Sequence Number: 4846846
• Product Code: MSD
• UDI-Device Identifier: H787103028185
• UDI-Public: H787103028185
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 10302818
• Device Lot Number: 5718821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male