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As reported, during a ureteroscopic holmium laser lithotripsy, an hiwire nitinol hydrophilic wire guide was not smooth.After an unknown manufacturer's ureteroscope entered the bladder and saline was used to activate the hydrophilic coating, the wire was placed through the ureteroscope working channel.The wire wouldn't advance smoothly and upon soaking the wire with saline again, it was still "stiff and astringent." a different wire was used to complete the procedure successfully.The wire guide holder was also flushed with sterile saline prior to removing the wire guide.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return evaluation of the wire guide, 0.25cm of the metallic core wire extended through the side of the polymer jacket 0.45cm from the distal tip.
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Name and address- street: (b)(6).Summary of event: as reported, during a ureteroscopic holmium laser lithotripsy, an hiwire nitinol hydrophilic wire guide was not smooth.After an unknown manufacturer's ureteroscope entered the bladder and saline was used to activate the hydrophilic coating, the wire was placed through the ureteroscope working channel.The wire wouldn't advance smoothly and upon soaking the wire with saline again, it was still "stiff and astringent." a different wire was used to complete the procedure successfully.The wire guide holder was also flushed with sterile saline prior to removing the wire guide.A section of the device did not remain inside the patients body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.One wire guide was returned to cook in open packaging in its wire guide holder.The hydrophilic coating was observed to have been activated by the customer and dried to the wire guide holder.The device was forwarded to the supplier for further evaluation.After flushing the dispenser assembly with saline, the device was removed from the dispenser and was subjected to visual and tactile examination.The device length and diameter measured within specification.The device coating appeared visually and tactilely consistent when examined at 1x ¿ 18 inches, unaided, wet.The device presented 0.25cm of the metallic core wire extending through the side of the polymer jacket 0.45cm from the distal tip.The polymer jacket material in the vicinity of the core wire penetration presented indications of tensile loading.The specimen also presented a large diameter bend over the distal 4.50cm, consistent with tensile loading.Except where noted, the specimen device appeared visually and dimensionally correct.A review of the supplier's device history records of the device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicated this product was final inspection tested and was determined to be acceptable.The supplier investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.The supplier was unable to assign a definitive root cause for the event as reported.A document-based investigation evaluation was also performed by cook.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the instructions for use (ifu).The following information is provided to the user related to the reported failure mode: instructions for activating hydrophilic coating the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.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.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.Based on the available information, cook has concluded a specific cause of the complaint cannot be established, though it was not possible to rule out handling and/or procedural factors as contributing to the complaint.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.
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