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E1- customer (person) phone: (b)(6).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, 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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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 unchanged, unknown, or unavailable.Correction: b1, b2, h1 = malfunction/no serious injury investigation ¿ evaluation it was reported by a physician from (b)(6) on (b)(6) 2023 that there was an incident with a hiwire nitinol hydrophilic wire guide (rpn: hws-035150, lot number 71003086) during a ureteroscopy procedure on (b)(6) 2023.A portion of the wire guide delaminated and separated in the patient's ureter while removing the wire guide.A crocodile clip and a ellick pear device were used to remove the retained device fragment from the patient.The procedure required additional time and the patient did not have any serious consequences.It was reported that the wire guide coating was activated with saline solution.The coating was kept hydrated while not it use and was reactivated before reuse.It was not placed through a needle but through an access sheath.The device was used only one time during the procedure, and there was no resistance encountered upon removal.A section of the device did not remain inside the patient¿s body, and the patient did not require any other additional intervention due to this occurrence after the device fragment was retrieved.The patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used hiwire nitinol hydrophilic wire guide was returned for investigation.The wire guide was returned with the product packaging indicating it was from lot 71002941.The returned complaint device was reviewed by the supplier who noted the specimen presented approximately 7.2 cm of skived/cut damage in a proximal to distal orientation located 28cm to 35.2cm from the distal tip, exposing the metallic core wire along with the indications of polymer jacket material damage.Except where noted, the specimen device appeared visually and dimensionally correct.The supplier also indicated the damage presented by the specimen appears consistent with manipulation of the guidewire against resistance.Additionally, a document-based investigation evaluation was performed.The wire guide is assembled and packaged by a supplier to cook who carried out an investigation as well as cook.A review of the device history record for lot 71003086 by cook and the supplier found no related anomalies.A database search carried out by cook found no other complaints have been reported for the complaint device lot.A review of manufacturing procedures by the supplier found multiple inspections to be in place to assure the integrity of the wire guide prior to shipment.The evidence from the complaint file, device history record, complaint history and the supplier evaluation of the complaint device indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Cook also reviewed product labeling.The wire guide was supplied with ifu t_hbwg2_rev1 which includes the following precautions: "manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access." "when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." instructions for activating hydrophilic coating: "the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating." based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event could not be established.It was not possible to rule out inadvertent user/procedural issues or concomitant device use.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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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