MAUDE Adverse Event Report: COOK ENDOSCOPY COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	CT-25M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product: boston scientific jagwire wire guide, unknown model.Erbe electrosurgical generator, unknown model.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.Separation of the cutting wire securing component and the catheter can occur if the tip of the sphincterotome is over flexed.The instructions for use caution the user not to over flex or bow the tip beyond ninety (90) degrees, as this may damage the sphincterotome.This type of damage can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is pre-curved and is provided with a pre-curved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of the sphincterotome to influence orientation, as this may result in damage to device.¿ if the elevator of the endoscope remained in the closed/up position when retraction of the sphincterotome was attempted and additional pressure was applied, this could have contributed to separation of the catheter and cutting wire securing component.The instructions for use caution the user the elevator should remain open/down when advancing or retracting the sphincterotome.This activity will aid in device preservation.Other factors that can contribute to separation of the cutting wire securing component and the catheter include manipulating the handle with the catheter in a coiled position or with the pre-curved stylet inside the cannulating tip.The instructions for use advise the user to uncoil and straighten the sphincterotome upon removing the device from the packaging.The user is then instructed to carefully remove the pre-curved stylet from the cannulating tip.The instructions for use contain the following comment: "note: do not exercise handle while device is coiled or pre-curved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." prior to distribution, all cotton cannulatome ii pc double lumen sphincterotome 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 isolated 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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook cotton cannulatome ii pc double lumen sphincterotome.Upon activating cutting energy [cutting function of the electrosurgical generator], the cutting wire got torn from one side [cutting wire broke in one location].On (b)(4) 2016, we received the following information: the cutting wire anchor disconnected at the patient end of device.No section of the device remained in the patient.
Additional Manufacturer Narrative
Initially, the following information was provided to cook: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook cotton cannulatome ii pc double lumen sphincterotome.Upon activating cutting energy [cutting function of the electrosurgical generator], the cutting wire got torn from one side [cutting wire broke in one location].On (b)(6) 2016, we received the following information: the cutting wire anchor disconnected at the patient end of device.No section of the device remained in the patient.An initial emdr was submitted on 03/17/2016 based on this information.On 11 april 2016, the device was received for evaluation.The cutting wire anchor was found to be secured to the catheter.The cutting wire was found to be broken on one side of the distal end of the device.No section of the device was found to be missing.Based on this device evaluation, this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional manufacturer narrative notes section for this justification.

• Brand Name: COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5507032
• Report Number: 1037905-2016-00060
• Device Sequence Number: 10825361
• Product Code: KNS
• UDI-Device Identifier: 00827002225374
• UDI-Public: (01)00827002225374(17)181110(10)W3641360
• Combination Product (Y/N): N
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CT-25M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2016
• Supplement Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1