An end user reported an issue with a bioflo chronic dialysis catheter 15.5f 28cm dual valve sheath basic kits.During this occurrence for patient b, the catheter placed on (b)(6) 2021 but was brought back in on (b)(6) 2021 due to a kink in the device.The catheter was removed and replaced.It was reported the catheter had not been accessed prior to this issue.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
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As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of catheter tubing kinked at patient's neck (i.E.Ij insertion site) cannot be confirmed as no dialysis catheter samples were returned and no x-ray images provided.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for the customer experience with these devices is end user placement technique and/or patient anatomy.This is also supported by fact that in four previously reported events from this account, devices were placed in the same patient (71 year old, male) with same kinked tubing result.(see below for report reference numbers).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 following is provided as a reference from dfu: insertion sites: the bioflo duramax dialysis catheter may be inserted percutaneously and is ideally placed in the jugular vein.Although this catheter may be placed in the subclavian vein, the internal jugular is the preferred site.Catheters greater than 40 cm length (tip to cuff) are designed for femoral vein insertion.Precautions: catheters placed via the femoral vein should be planned carefully in terms of insertion site, tunnel, and exit site.Consideration should be made of the possibility of permanent access in that limb.If an arteriovenous fistula or graft may be created in that limb, then placement of a catheter in the anatomy of that limb should be avoided if at all possible.Exit sites and tunnel tracts should be chosen carefully so as to: minimize interference with patient mobility.Maximize patient comfort.Maintain as wide and gentle a curve as possible to minimize potential for catheter kinking.Minimize infection risk.Minimize catheter length (while allowing for the prior considerations) so as to maximize the potential blood flow of the catheter.Catheters placed via the femoral vein will generally have lower blood flow than catheters placed via the internal jugular vein.Warning: do not over-expand subcutaneous tissue during tunneling.Over-expansion may delay/prevent cuff in-growth.Note: a tunnel with a wide gentle arc lessens the risk of kinking.The tunnel should be short enough to keep the y-hub of the catheter from entering the exit site, yet long enough to keep the cuff 2 cm (minimum) from the skin opening.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).The previously reported events from this account as noted in the above narrative were submitted under: 1317056-2022-00009 1st device, angiodynamics' reference (b)(4).1317056-2022-00010 2nd device, angiodynamics' reference (b)(4).1317056-2022-00012 4th device, angiodynamics' reference (b)(4).
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