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During an endoscopic retrograde cholangiopancreatography (ercp) procedure for stone removal, the physician used a cook acrobat¿ calibrated tip wire guide.It was reported that the front end of the duodenoscope reached the duodenal papilla, and the cook three-lumen sphincterotomy (tri-25m) was used together with the acrobat guidewire (acro-35-450) for common bile duct intubation.The guide wire cavity of the incision knife was fully rinsed with saline.Before inserting the acrobat guide wire into the guide wire cavity of the incision knife [cutting wire], it was thoroughly rinsed with saline and infiltrated with gauze, then common bile duct intubation was performed.The angiography showed that the bile duct was intubated.Multiple filling defects were seen in the middle section of the common duct, with a maximum diameter of about 10 mm; then the duodenal papilla was incised with an incision knife [cutting wire].The [sphincterotome] was withdrawn, and the (fs-bdb-104) cylindrical balloon guidewire cavity was fully flushed.The guide wire was extended into the cylindrical balloon for dilation.After the expansion was completed, the guide wire was left in place and the cook-(msb-2x4) mesh basket was used to repeatedly try to remove the stones.Multiple stones were successfully removed one by one, and the basket was withdrawn; the three cook chambers were fully flushed with saline.The guide wire cavity of the balloon lithotomy catheter (txr-8.5-12-15-a) was flushed, then the lithotomy balloon was guided slightly along the guide wire.When the balloon reached the lower section of the common bile duct and encountered resistance and could not move forward, the lithotomy balloon was withdrawn for twelve seconds.Outside the intestinal papilla, the guide wire was withdrawn.Under the microscope, long sections of the acrobat guide wire skin were peeled off and gathered together [coating damage], so the lithotomy balloon and acrobat guide wire were withdrawn; the [tracer] guide wire (metii-35-480) was then replaced and the incision was made.The knife (tri-25m sphincterotome) was used to re-intubate [loss of wire guide access].After achieving success, the [tracer] guide wire was left in place, and the cook three-lumen balloon lithotomy catheter( txr-8.5-12-15-a) was introduced along the [tracer] guide wire to clean the bile duct.Once the cleaning was completed, the lithotomy balloon was withdrawn.The [tracer] guide wire was inserted along the elbow nasobiliary duct to complete the operation.A section of the device did not remain inside the patient¿s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.
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Investigation evaluation: the product said to be involved was returned in a white plastic bag, provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.A section of the coating has split and peeled exposing the core wire approximately 19.5cm to 26.9cm from the distal end.The coating was partially socked over on itself from 12.7cm to 19.5cm from the distal tip.A shallow cut in the coating continuing from the peeled section was observed under magnification, evidence of potential scoring damage contributing to the failure.No portion of the coating appears to be missing.A lab meeting was held with manufacturing engineering and photos were reviewed by production leadership on (b)(6) 2024.A visual inspection of the coating damage confirmed evidence of a scoring defect.This is the most likely cause for the coating damage.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our evaluation of the returned device confirmed the report.The coating at the distal end was damaged in manufacturing during the scoring process.This occurred due to operator error.Production management and the department team leads were notified of this occurrence.Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint.Retraining of the operator has been completed.A corrective action (capa) was initiated to investigate device failure related to coating damage caused by the scoring fixture.This device is within the scope of the capa.Prior to distribution, all acrobat¿ calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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