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Catalog Number 10302804 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the disposable 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).Please reference reports: 1317056-2022-00009 1st device, angiodynamics' reference (b)(4).1317056-2022-00010 2nd device, angiodynamics' reference (b)(4).1317056-2022-00011 3rd device, angiodynamics' reference (b)(4).1317056-2022-00012 4th device, angiodynamics' reference (b)(4).
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Event Description
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Device 1 of 4: an end user reported an issue with 4 bioflo chronic dialysis catheter 15.5f 28cm dual valve sheath basic kits.It was reported that during 4 separate occurrences with the same patient, implanted catheters have developed a kink, in the patient's neck.During this occurrence, the device was placed on (b)(6) 2021, re-positioned on (b)(6) 2021, and ultimately needed to be removed on (b)(6) 2021, due to the kink.The kink was noted via imaging.It was reported that no treatments or access was made to the catheter prior to the issue.
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Manufacturer Narrative
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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 the four devices were placed in the same patient (71 year old, male) with same kinked tubing result.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: 1.Minimize interference with patient mobility.2.Maximize patient comfort.3.Maintain as wide and gentle a curve as possible to minimize potential for catheter kinking.4.Minimize infection risk.5.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).Please reference reports: 1317056-2022-00009 1st device, angiodynamics' reference (b)(4).1317056-2022-00010 2nd device, angiodynamics' reference (b)(4).1317056-2022-00011 3rd device, angiodynamics' reference (b)(4).1317056-2022-00012 4th device, angiodynamics' reference (b)(4).
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Search Alerts/Recalls
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