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In additional information received on (b)(6)2021, it was reported that difficulty was experienced when inserting the wire guide into the needle.As the physician attempted to pull the wire guide back, it became stuck in the needle and would not move.The physician then took the needle and wire guide out of the patient's body together.The wire was forcibly pulled out of the needle and it was observed that the wire had unraveled.When the tip of the needle was checked, it was found to be crushed.Another device was then used to complete the procedure.
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: b5, d10.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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Investigation ¿ evaluation.An issue was reported with the wire guide from a lock pericardiocentesis catheter set (c-pcs-830-lock) from lot 9359570.Advancement of the wire guide into the needle was difficult.The user attempted to withdraw the wire guide through the needle, but the wire became stuck.Both the wire and needle were removed together.The user then attempted to forcibly pull the wire guide out of the needle once it was removed from the patient, leading to unraveling.Cook became aware of this event on (b)(6) 2020 upon being notified by chikamori hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One wire guide and needle were received in used and damaged condition for evaluation.The wire was found to be lodged in the needle and the coil was elongated with the safety wire exposed.When the wire was able to be pulled from the needle, the distal weld was observed to be missing.A small piece of covered biological matter was pushed out of the needle as a different wire was inserted.The piece was cleaned and discovered to be the distal weld and a small section of coil.The coil outer diameter and needle inner diameter were measured and found to be within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) showed that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 9359570 and relevant subassembly lot ic9210657 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information related to the reported failure mode: instructions for use 6.Insert the wire guide through the needle and advance the wire guide into the pericardial sac.Note: the wire guide should advance without resistance.How supplied upon removal from package inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the action of withdrawing the wire guide through the needle contributed to the wire guide separation.However, as there were issues with advancement of the wire guide into the needle, this cannot be definitively confirmed.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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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