Initially, the following information was provided to cook: during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon.The extraction balloon broke during the first trawl [sweep] of the duct.The physician stated that he did not exert any unusual pressure on the balloon during these procedure.A new balloon was required to be opened to complete the procedure.A section of the device did not remain inside the patient¿s body, other than removing the device portion through the endoscope in the initial procedure.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.An initial mdr was submitted on 8/5/2015 based on this information.The following clarification was received on 8/6/2015: the balloon split [rupture] while trawling [sweeping] the biliary duct.There was not any product retained by the endoscope.The broken [ruptured] balloon was removed through the channel of the endoscope and a new one opened.There was no part of device that detached during the procedure.The balloon just seemed to split [rupture].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.Based on this information, this incident no longer meets the reporting criteria of a fda mdr report.
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