MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC UTS PRECURVED ULTRA TAPER SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	UTS-25M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) # k172665.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The detached portion of the cutting wire has been taped to the exterior of the pouch.Our evaluation of the product said to be involved confirmed the report.The cutting wire has broken and a portion detached.Due to the breaks in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.The cutting wire exhibits slight evidence of a cautery application (blackening of the cutting wire was noted at the proximal end of the cutting wire).All sections of the cutting wire are present.A clear substance was observed within the catheter.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: our evaluation of the returned device confirmed the cutting wire is broken an a portion detached.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.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 the tip beyond 90 degrees, as this may damage or cause the cutting wire to break.".Cutting wire breakage can occur 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 cutting wire breakage.The instructions for use caution the user with the following comment: ¿the elevator should remain open/down when advancing or retracting the sphincterotome.¿ the instructions for use also instructs the user with the comment: ¿advance the tip of the sphincterotome into the endoscope accessory channel and continue to advance in short increments until the device is endoscopically visible.¿.Prior to distribution, all uts precurved ultra taper sphincterotomes 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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook uts precurved ultra taper sphincterotome.It was reported that a sphincterotomy was attempted (partially completed) with a cook wire guide in the sphincterotome into the cbd (common bile duct) and the cutting wire completely detached from the sphincterotome.It became slightly embedded in the tissue.The defective sphincterotome was removed leaving the wire guide, and then a new device was advanced.The second sphincterotome was able to complete the sphincterotomy and it was removed.The second sphincterotome was removed and a smooth edged grasper was advanced down the scope.It was able to grab the cutting wire and be removed successfully.Once the cutting wire was removed, a plastic stent was placed and the case was finished successfully.No adverse effects were reported.A section of the device did not remain inside the patient¿s body.The cutting wire completely detached from the sphincterotome and became slightly embedded in the tissue.A smooth edged grasper was advanced down the scope to grab the wire fragment.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105
• MDR Report Key: 19527714
• Report Number: 1037905-2024-00324
• Device Sequence Number: 15343553
• Product Code: KNS
• UDI-Device Identifier: 00827002224902
• UDI-Public: (01)00827002224902(17)270318(10)W4820806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UTS-25M
• Device Lot Number: W4820806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC ERCP CANNULA 5-4-3 TIP.; COOK MTII-21-480 WIRE GUIDE.; ENDOSCOPE, UNKNOWN MAKE AND MODEL.; SMOOTH EDGED GRASPER, UNKNOWN MAKE OR MODEL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male