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D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b - product code: additional product codes: gbo; lje.G4 ¿ pma/510(k) #: k173035.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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It was reported that the flexible stiffener of an ultrathane mac-loc locking loop multipurpose drainage catheter was difficult to advance.The customer reported the stiffeners were lubricated to aid advancement into the catheter; however, advancement was still "snug".Two additional drains were obtained to complete the procedure which resulted in a longer procedure time.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device was received by cook on 04dec2023.Preliminary device failure analysis noted the stiffener was elongated and bent, indicating difficult removal, thus prompting this report.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation it was reported that the flexible stiffener of an ultrathane mac-loc locking loop multipurpose drainage catheter was difficult to advance.The customer reported the stiffeners were lubricated to aid advancement into the catheter; however, advancement was still "snug".Two additional drains were obtained to complete the procedure which resulted in a longer procedure time.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used device in a prepped and damaged condition was returned to cook for evaluation.Upon visual inspection, the flexible stiffener was partially inserted into the drainage catheter.Upon removing the stiffener, material elongation was confirmed to be present.Additionally, two bends in the shaft were also present.One was noted just proximal to the hub and the other from the distal end of the hub.A dissection of the catheter was performed.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.To date, a further search of our database records confirmed one additional complaint from the same user facility, reporting the same difficulty.Cook reviewed the product labeling.The product ifu, [t_multi2_rev1] ¿multipurpose drainage catheter" contains the following in relation to the reported failure mode: "precautions: when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, ifu, dhr and device evaluation suggests that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the root cause category would fall under cause traced to component failure without any design or manufacturing issue.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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