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Catalog Number TRI-25M-P
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: an evaluation of the photo provided by the user showed the cutting wire securing component located near the distal end of the sphincterotome disconnected from the catheter. Our laboratory evaluation of the device returned confirmed the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter. The cutting wire is intact and remains securely attached to the sphincterotome at the proximal end. However, due to the catheter and securing component disconnection, the distal end of the cutting wire is no longer connected to the sphincterotome catheter at the distal end. No section of the sphincterotome device is missing. A visual examination of the catheter showed a bend 85 cm from the distal end. The catheter also showed an area that was flattened between 117 cm and 119 cm from distal end of the device. A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed. 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: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break. " in the additional information provided, the user mentioned that the distal end of the catheter was formed manually. 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 sphincterotome to influence orientation, as this may result in damage to device. ¿ if the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and additional pressure is applied, this could have contributed to separation of the catheter and cutting wire securing component. The instructions for use caution the user: "elevator should remain open/down when advancing or retracting 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 precurved stylet inside the cannulating tip. The instructions for use advise the user: ¿upon removing device from package, uncoil and straighten sphincterotome. " the user is then instructed: "carefully remove precurved stylet wire from cannulating tip. ¿ the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable. " the instructions for use advise 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. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout procedure. " prior to distribution, all tri-tome pc protectors 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. 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. Additional comments regarding this report: based on the information provided that user manually formed the distal end of the catheter, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tri-tome pc protector. After the product was advanced over the wire guide, it was found that the cutting wire cut [broke] before connecting to electricity. The device was replaced to a new product and the procedure ended. A picture of the device was provided, based on the picture the cutting wire securing component separated from the catheter.
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key6450585
MDR Text Key71476315
Report Number1037905-2017-00134
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberTRI-25M-P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/08/2017
Device Age5 MO
Event Location Hospital
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2016
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: 03/31/2017 Patient Sequence Number: 1