WILSON-COOK MEDICAL INC. ACROBAT CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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Catalog Number ACRO-25-260 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Hemostasis (1895); Perforation (2001)
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Event Date 01/06/2014 |
Event Type
Injury
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook acrobat calibrated tip wire guides.They first attempted to cannulate using a boston scientific dreamtome with a.035" dreamwire but were unsuccessful.The wire went into the pancreas without fluoroscopy.They then attempted using the dreamtome with the first cook acrobat wire guide in order to get into the common bile duct, with no success.See mdr 1037905-2014-00049.They attempted to use a boston scientific needle knife but it wouldn't go up into the common bile duct.Another attempt was made using the dreamtome and the second acrobat wire guide, see mdr 1037905-2014-00050.After several attempts they were able to cannulate the common bile duct.Fluoroscopy was performed and the biliary tree was visualized.The papilla was cut using the dreamtome and the common bile duct began to bleed.They used 10 cc of adrenaline.It was still difficult to move the sphincterotome, the physician decided to make a dilation with a hurricane 4x4 mm tamponade to stop the bleeding with success.They tried to place a boston scientific wallflex tent, but the catheter could not be advanced completely.The physician decided to change the wire guide back to a dreamwire.A second dilation was performed with a hurricane 4x6 mm like tamponade.They attempted to pull the placed stent into place but there is a lot of bleeding that made it difficult to deploy.The blood bothered the visualization.The physician decided to stop the procedure at this time and call the radiology area.The physician was not certain what caused the perforation.They never said it was the fault of the acrobat wire guide, but it was the only device that advanced through to the tumor.Other than the place stent, a section of the device did not remain inside the pt's body.The pt was sent to radiology and the scan performed immediately after the ercp.The scan observed the stent in place but not in the common bile duct.It was in the pancreatic location and not the intended biliary.The stent was through the parenchyma and a part was in the portal vein.The vascular physician decided to wait a week to get more details on the pt's cancer.The pt was stable without pain or bleeding.After one week, the pt had a dpc (duodeno-pancreatic surgery).It was easy and pt was doing fine.
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Manufacturer Narrative
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Investigation evaluation: a product eval was not performed in response to this report because the product said to be involved was not provided to cook for eval.The report could not be confirmed.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 conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for eval.A definitive cause for the reported observation could not be determined.The instructions for use state, "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The instructions for use state, "potential adverse events associated with ercp include, but are not limited to perforation." prior 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 mfg requirements prior to shipment.Correction action: a review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessement.Qa will continue to monitor for complaint trends and assesses the risk assessement results as post market feedback continues to become available.
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