MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACROBAT CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number ACRO-25-260

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemostasis (1895); Perforation (2001)

Event Date 01/06/2014

Event Type  Injury  

Event Description

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 stent, 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 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 placed stent, a section of the device did not remain inside the patient's body.The patient 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 patient's cancer.The patient was stable without pain or bleeding.After one week, the patient had a dpc (duodeno-pancreatic surgery).It was easy and patient was doing fine.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.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 evaluation.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 not limited to perforation." 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 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 assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: ACROBAT CALIBRATED TIP WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3640704
• MDR Text Key: 4281926
• Report Number: 1037905-2014-00050
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K122816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Catalogue Number: ACRO-25-260
• Device Lot Number: W3291732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC DREAMTOME (UNK MODEL NUMBER); OLYMPUS TJF-160 VR ENDOSCOPE; BOSTON SCIENTIFIC DREAMWIRE (UNK MODEL NUMBER); HURRICANE 4X4MM TAMPONADE (UNK MODEL NUMBER)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR