Concomitant medical products : mtw ercp catheter, 215 cm, 0.025", unknown reference part number.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The tip of the device was bent at approximately 3 cm from the distal end.Approximately 11.8 cm to 13.8 cm from the distal end is a section of bare core wire with intact coating attached at either end.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history records for the wire guide lot was reviewed.The wire guide device history record contains a nonconformance that could potentially be related to wire guide damage.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all acrobat® 2 calibrated tip wire guides are subjected to a visual inspection and functional testing 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: corrective action is not warranted at this time based on the quality engineering risk assessment.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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During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat® 2 calibrated tip wire guide.Procedure for replacing a bile duct stent was performed.Wire-guided-cannulation was performed from the side of the stent with the wire guide and another manufacturer's ercp catheter.The ercp catheter did not have a metal tip.After that, the ercp stent [catheter] was removed and the wire guide remained at the side of the stent.Then, the user attempted to remove the stent but coating material of the wire guide peeled off during removal of the stent.Another wire guide was used instead [lost wire guide access] [subject of this report].There have been no adverse effects to the patient reported.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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