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It was reported that the guide wire of a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set became stuck and unraveled/frayed during insertion of the device into the patient's right femoral vein.Upon fraying, the wire was unable to be removed, requiring sedation and immunosuppressant medications for the patient.The first pass cannulation into the femoral vein was successfully completed advancing the wire approximately 2.5-3.0 cm deep.The wire was described to have "passed easily" and was visualized in the femoral vein.The dilator was then advanced "easily" over the wire (2x serial dilation).As the catheter was passed over the wire, the wire gradually pulled out and was noted to be frayed.Upon attempting to remove the wire, it became more frayed and had two visible exit points from the patient's skin.At this point, approximately 25 cm of the wire was inside the patient.Forceps were used to secure two parts of the wire and to prevent loss of the wire in the patient.The wire was still able to be visualized in the vein and was attempted to be removed by a minor skin incision.A vascular physician was contacted and was able to remove the wire from the patient bedside in the icu, resulting in one stitch in the patient's right groin.The patient was described to be in a "meticulous position" and was said to have a "large abdominal apron".
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.It was reported that a wire guide from a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set (c-uqlm-1001j-rsc-abrm-hc-rd-au) from lot 10292115 became frayed during insertion.Specifically, the wire guide frayed as the catheter was advanced over the wire guide.Attempts to remove the wire caused more fraying, eventually requiring a minor skin incision to remove it in entirety.Cook became aware of this event on 18jun2020 upon being notified by royal melbourne hospital.The patient reportedly experienced no additional adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos of the device were provided to cook showing the wire guide coil unraveling in multiple areas.The inner mandril also appeared separated.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (10292115) and the related wire guide sub-assembly lot revealed no non-conformances related to the failure mode.A database search found no other events associated with the reported device lot.Given this information, cook has concluded that there is no evidence of non-conforming product existing either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ctulmabrmau_rev1 [cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿precautions standard seldinger technique for placement for placement of percutaneous vascular access sheaths, catheters and wire guides should be employed during the placement of a central venous catheter.Instructions for use 4.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation, a definitive root cause has been traced to component failure without a manufacturing/design deficiency.It is possible that during advancement, the catheter caused the wire to kink within the vessel, becoming damaged and eventually unravelling.The wire guide may have also been pre-bent prior to insertion, facilitating this potential failure.However, these possibilities cannot be confirmed without return of the device and/or additional procedural information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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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