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

Catalog Number CCPT-25ME

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: two used devices were received.An evaluation of the two used devices was performed.Device one (1): our evaluation of the returned device confirmed the report and determined a section of the cutting wire was missing.The cutting wire has broken and approximately 13 mm of the cutting wire remains attached.Due to the break in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.A section of the cutting wire detached and was not returned with the device, estimated to be 12 mm in length.The cutting wire exhibits evidence of a cautery application (blackening of the cutting wire was noted).A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.Device two (2): our evaluation of the returned device confirmed the report.A visual examination of the device confirmed cutting wire breakage.No portion of the cutting wire was missing during the initial evaluation, however, after the decontamination process, the distal portion of the broken wire became detached and could not be located.The broken portion that detached is estimated to be approximately 25 mm.Due to the break in the wire, the sphincterotome will not respond to handle manipulation and is no longer operational.The wire showed evidence of a cautery application (blackening of the cutting wire was noted).No section of the cutting wire was initially missing but a portion detached during the course of the evaluation.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.In addition, due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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 occur if the handle is manipulated with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user to: ¿upon removing device from package, uncoil and straighten sphincterotome." the user is then instructed to: ¿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." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions 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." 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 contribute to cutting wire breakage.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome."this activity will aid in device preservation.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.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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cotton cannulatomes.The cutting wire broke on both devices.There was no reportable information at this time.The devices were received for evaluation on 5/9/2017.It was observed that one of the cutting wires was broken and a section was missing.During initial evaluation of the second device it was observed the cutting wire broke in the middle [cutting wire broke in one location] and both pieces remained attached to the device and no portion of the cutting wire was missing.However, during further evaluation of the device a section of the cutting wire broke and detached.

• Brand Name: COTTON CANNULATOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6608527
• MDR Text Key: 76627873
• Report Number: 1037905-2017-00340
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002227323
• UDI-Public: (01)00827002227323(17)180805(10)W3602716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CCPT-25ME
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1