|
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.
|
|
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 in the patient's vessel and was unable to be retrieved.The separated portion of the wire was retained in the vessel for more that 24 hours.An endovascular procedure was scheduled to remove the wire fragment.Subsequently, an x-ray was taken to ensure no other wire fragments were retained in the patient.No other adverse effects were reported for this incident.
|
|
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.
|
|
Correction: d4-model#, d9- device available for eval, h3: device evaluated by mfg.Investigation ¿ evaluation.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 in the patient's vessel during the dilation process when the dilator passed over the guide.It was noted that the wire guide was manipulated in the needle.The separated portion was unable to be retrieved and was retained in the vessel for more than 24 hours.An endovascular procedure was scheduled to remove the wire fragment.Subsequently, an x-ray was taken to ensure no other wire fragments were retained in the patient.It is unknown if the patient had tortuous anatomy.No other adverse effects were reported for this incident.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 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 instructions for use (ifu) [c_t_rdulm_rev5] supplied with the complaint lot were reviewed for information related to the reported failure mode.Per the ifu: ¿instructions for use.4.Slide safe-t-j wire guide straightener (positioned on the distal tip of wire guide) over ¿j¿ portion of wire guide.Pass straightened wire guide through needle; advance wire guide 5-10 cm into vessel.If straight wire is used, always advance soft, flexible end through needle hub and into vessel.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 while inside the needle and causing 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.
|
