TANDEM RX CANNULA

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 06/19/2009, THAT A TANDEM REX CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2009. ACCORDING TO THE COMPLAINANT, AN ERCP WAS COMPLETED WITH THIS DEVICE. A LITHOTRIPSY PROCEDURE WAS THEN PERFORMED WITH ANOTHER DEVICE AND A RETRIEVAL BALLOON. FOLLOWING THE LITHOTRIPSY, A CONTRAST TEST WAS CONDUCTED AND IT WAS NOTICED THAT RO MARKER OF THE CANNULA REMAINED IN THE BILE DUCT. THE PHYSICIAN INDICATED HE WAS CONCERNED THAT THE RO MARKER REMAINED IN THE DUCT. HOWEVER, THE PROCEDURE WAS COMPLETED AT THAT TIME. ANOTHER PROCEDURE WAS RESCHEDULED FOR ONE WEEK LATER, FOR RETRIEVAL OF THE MARKER. ON THAT DAY, THE PT UNDERWENT A CONTRAST TEST. THE RO MARKER WAS NOT FOUND. THE PHYSICIAN INDICATED THAT THE RO MARKER HAD MOST LIKELY BEEN ELIMINATED VIA NORMAL PERISTALSIS. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.