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It was reported that the wire guide from a five lumen polyurethane central venous catheter set separated.During placement of the central venous catheter (cvc), the wire guide frayed then broke at the insertion site.The portion of the wire that remained in the vessel was carefully extracted with forceps.Subsequently, an x-ray was taken to ensure no fragments of the wire were retained in the patient.It was also noted that the difficulty with cvc placement "delays timely attention to the patient's admission pathology".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Blank fields on this form indicate the information is unknown or unavailable.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 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 or that a death or serious injury occurred; nor is it admission 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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 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 or that a death or serious injury occurred; nor is it admission 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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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: d4-model#, d9- device available for eval, h3- device evaluated by mfg, h6- annex a investigation ¿ evaluation it was reported that, on 06feb2024 the wire guide in a five lumen polyurethane central venous catheter set from broke.The physician indicated that the wire guide broke after the dilator had passed over the wire guide.The wire had been manipulated while inside the needle.All fragments were removed from the patient during the initial placement procedure.It is unknown if the patient had tortuous anatomy.X-rays were needed to assure the wire had had been removed.It was also noted that the difficulty with cvc placement "delays timely attention to the patient's admission pathology".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device found one possible relevant recorded nonconformance that could have contributed to the reported failure mode, in which the nonconforming device was scrapped.It should be noted that there was one other complaint associated with the final product lot number.Cook also reviewed product labeling: the product ifu, [c_t_rdulm_rev5] ¿uncoated and heparin-coated central venous catheters,¿ provides the following information to the used related to the reported failure mode: 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.¿ evidence gathered upon review of dmr, product labeling, and dhr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no product returned, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It is possible that the customer withdrew the wire slightly during manipulation while inside the needle and caused the wire to break.However, cook cannot confirm this without more information.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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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