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Catalog Number CCPT-25ME
Device Problem Material Separation (1562)
Patient Problems Sepsis (2067); Bowel Perforation (2668)
Event Date 08/02/2021
Event Type  Death  
Manufacturer Narrative
Pma/510(k) # k172665. 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 conclusion: 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 ifu lists the potential complications: "potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest. " a broken cutting wire can occur if the tip of the device is over flexed. The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break. " cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform sphincterotomy. The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope. " the instructions for use caution the user: contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope. " if the sphincterotome is used with excessive electrosurgical current settings provided by the electrosurgical unit, this can contribute to cutting wire breakage. The instructions for use direct the user: before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. " prior to distribution, all cotton cannulatomes are subjected to a visual inspection and functional test to ensure device integrity. The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation. 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. 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.
Event Description
During a double balloon enteroscopy, the physician used a cook cotton cannulatome. As soon as the doctor put his foot on the coagulation pedal, the sphincterotome wire was broken. He could not finish the papillotomy. They decide to stop the procedure. Patient was in pain and on the computed tomography (ct) scan they discovered a perforation. The patient went to intensive care and died on (b)(6) (20 days post procedure). It is unclear if the patient died due to the perforation. Further information was received stating that after the procedure, the physician was not sure if the papillotomy caused the perforation or if it was made with the endoscope. The ct scan conclusion was that the perforation/air was around the papilla. The physician stated that he was "only able to coagulate/cut a little of the papilla, so that he could not believe that caused the perforation but it seems to be the case. " a call was held on 09/28/2021 with the physician involved. The following was determined from the call: the patient had a previous whipple with roux en y procedure and a double balloon enteroscopy was being done to perform ercp. The user cannulated and was doing some bowing to maneuver the sphincterotome due to the altered anatomy. An erbe vio 3 was being used with the pre-installed settings for sphincterotomy. Upon pushing the pedal to activate the electrosurgical generator, the cutting wire of the sphincterotome broke on two ends and became loose in the bowel lumen. No sphincterotomy was performed before the cutting wire broke. The physician tried to take it out. They were able to remove the detached portion with the endoscope. The next day the patient was having pain. Air and fluid were found at the papilla, indicating a perforation. The patient was in the icu for 9 days and became septic. The patient passed away at 20 days. A section of the device did not remain in the patient's body; the detached portion of the cutting wire was removed. The patient had a perforation during the procedure and went to intensive care and died on (b)(6) 2021, 20 days post procedure. It is unclear if the patient died due to the perforation.
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key12633300
MDR Text Key276426249
Report Number1037905-2021-00573
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCCPT-25ME
Device Lot NumberW4374937
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1