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It was reported that a hiwire nitinol hydrophilic wire guide was difficult to remove from a disposable two-part trocar needle.The wire guide was placed under x-ray through the sheath of the trocar needle during a left supine percutaneous nephrolithotomy procedure for an unknown patient.Access to the kidney was achieved, and the inner trocar of the needle was removed before placing the wire guide through the outer sheath of the needle.No resistance was reported.The wire was manipulated in order to place the wire down the ureter.However, in this process the wire would not move any more.Attempted withdraw of the wire guide was unsuccessful.Therefore, they attempted to pull the wire through via a retrograde approach using another manufacturer's disposable ureteroscope and a cook flexor ureteral access sheath.Further attempts to withdraw the wire via a needle sheath revealed the coating had been stripped from the wire leaving a bare wire section.Dilation was continued with fascial dilator sets followed by a nephrostomy balloon catheter.A dual lumen ureteral access catheter was used to exchange the wire for a new wire guide.When the needle and sheath were put back together on the scrub table, they noticed wire guide coating obstructing the distal end of the needle sheath.In additional information received from the customer on (b)(6) 2023, it was stated that portions of the wire guide coating within the patient were retrieved with alligator tooth retrieval forceps and ngage nitinol stone extractor.There was then no evidence of any further coating remaining in the patient, and it was deemed to have all been removed.With the new wire in place the case continued and was successfully completed.This complaint will address the disposable two-part trocar needle.Another related complaint under patient identifier (b)(6) will address the hiwire nitinol hydrophilic wire guide.No section of the device remained inside the patient's body.No other adverse effects were reported for this incident.
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Blank fields on this form indicate the information is unknown or unavailable.D10/d11: concomitant medical products: concomitant medical products: cook hiwire nitinol hydrophilic wire guide ( catalog number hw-035150), cook fascial dilator sets (catalog numbers 072008, 072101, 072012), cook dual lumen ureteral access cather (catalog number 022610), cook ultraxx nephrostomy balloon catheter and set (catalog number unbs-10-15-cs), cook flexor ureteral access sheath (catalog number fus-120045), boston scientific utereroscope.G4- pma/510(k) #: k183035.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.Investigation ¿ evaluation.It was reported that a hiwire nitinol hydrophilic wire guide was difficult to remove from a disposable two-part trocar needle.The wire guide was placed under x-ray through the sheath of the trocar needle during a left supine percutaneous nephrolithotomy procedure for an unknown patient.Access to the kidney was achieved, and the inner trocar of the needle was removed before placing the wire guide through the outer sheath of the needle.No resistance was reported.The wire was manipulated in order to place the wire down the ureter; however, in this process the wire would not move any more.Attempted withdraw of the wire guide was unsuccessful.Therefore, they attempted to pull the wire through via a retrograde approach using another manufacturer's disposable ureteroscope and a cook flexor ureteral access sheath.Further attempts to withdraw the wire via a needle sheath revealed the coating had been stripped from the wire leaving a bare wire section.Dilation was continued with fascial dilator sets followed by a nephrostomy balloon catheter.A dual lumen ureteral access catheter was used to exchange the wire for a new wire guide.When the needle and sheath were put back together on the scrub table, they noticed wire guide coating obstructing the distal end of the needle sheath.In additional information received from the customer, it was stated that portions of the wire guide coating within the patient were retrieved with alligator tooth retrieval forceps and ngage nitinol stone extractor.There was then no evidence of any further coating remaining in the patient, and it was deemed to have all been removed.With the new wire in place the case continued and was successfully completed.This complaint will address the disposable two-part trocar needle.Another related complaint under patient identifier (406702) will address the hiwire nitinol hydrophilic wire guide.No section of the device remained inside the patient's body.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.A device failure analysis was conducted on the returned device.A wire guide and disposable two-part trocar needle were returned without packaging.The needle was returned heavily soiled with an unknown biomatter, and the trocar could not be removed from the cannula.Wire guide coating was noted protruding 3 mm from the cannula of the needle.The wire guide was investigated by the supplier who noted skived/cut damage at 1.5cm from the distal tip exposing the metallic core wire along with the polymer jacket material removal and kink/bend damage.The specimen also presented skived/cut damage in a proximal to distal orientation located 18.9 cm to 38.5cm and 109cm to 109.5 cm from the distal tip exposing the metallic core wire along with the polymer jacket material damage.Except where noted, the specimen device appeared visually and dimensionally correct.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr records nonconformances for "transition poor" that are possibly similar to the reported failure mode.However, the nonconforming devices (quantity - 5) were scrapped prior to lot release.A database search for complaints on the reported lot found no additional complaints reported from the field.Because adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there was no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The product ifu, t_dtptn_rev0; the ifu did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a cause for the complaint cannot be established.It is not possible to rule out inadvertent user/procedural issues contributing to the complaint.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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