Investigation ¿ evaluation: az-groeninge in belgium contacted cook stating that during a treatment of a patient, the wire guide from a lock pericardiocentesis catheter set unraveled.The wire guide unraveled when the catheter was in place and the wire guide was withdrawn.The wire guide was from a c-pcs-830-lock set from lot# 10066741.The wire guide was removed, and an x-ray confirmed that no part of the wire guide was left within the patient.There were no adverse effects for the patient and the patient did not require any additional procedures.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device, as well as a visual inspection of photos provided by the customer, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did provide photographs to aid in the investigation.The photographs show the wire guide in an unraveled state.Additionally, a document based investigation evaluation was performed.The device master record (dmr) was reviewed and this product is 100% inspected for defects.The device history record for lot 10066741 was reviewed.The lot and relevant subassembly lots had no related nonconformances.A database search found no additional complaints on this lot.There is no evidence of nonconforming material in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: a tfe-coated wire guide must be used with the catheter in this set.Only the wire guide included in this set should be used with this catheter.Instructions for use: 5.Slide the safe-t-j wire guide straightener (positioned on the distal end of the wire guide) over the ¿j¿ portion of the wire guide and seat the straightener in the hub of the needle.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.7.Leaving the wire guide in place, remove the needle.Create a small skin incision.If a dilator is included in set, the dilator should be advanced over the wire guide and removed prior to insertion of the catheter.9.Introduce the catheter (with stiffening cannula, if applicable) over the wire guide and advance until the tip of the catheter is posterior to the muscle fascia.11.Advance the catheter into the pericardium.Note: the wire guide should always extend beyond the catheter tip.12.Remove the wire guide.How supplied: upon removal from package inspect the product to ensure no damage has occurred.Based on the device master record, the device history record, and with no product return, it was determined the device was manufactured to specification.The customer provided photographs to aid in the investigation showing the wire guide in an unraveled state.The customer stated that the wire was not removed through the needle, as the needle had already been removed.The wire was noticed unraveled when it was removed for the catheter.This product is 100% inspected for defects.Based on the provided information, the cause of this event is component failure without design or manufacturing deficiency.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.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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