MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SNAPLOC WIRE GUIDE LOCKING DEVICE; ODC ENDOSCOPE CHANNEL ACCESSORY

Catalog Number	SNAPLOC-O
Medical Device Problem Codes	Accessory Incompatible (1004); Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k213483.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.However, the information provided indicated a cook delta wire guide was used which is a fully hydrophilic coated wire guide.The ifu states: "for optimal performance, utilize device with non-fully hydrophilic coated.025" and.035" cook wire guides." this is the most likely cause for the reported difficulty.Prior to distribution, all snaploc wire guide locking devices are subjected to a visual inspection and functional testing to ensure device integrity.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.Additional comments: based on the information provided that a cook delta wire guide was used which is a fully hydrophilic coated wire guide, 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook snaplock wire guide locking device.It was reported that "the wire kept 'buckling-out' [wire looping at the snaplock] during wire exchanges.The physician switched to a competitors sphincterotome and wire guide device to complete the intended procedure successfully." the information provided indicated that a cook wire guide was used and later replaced with a competitors wire guide.This is being interpreted as loss of wire guide access.[subject of report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: SNAPLOC WIRE GUIDE LOCKING DEVICE
• Common Device Name: ODC ENDOSCOPE CHANNEL ACCESSORY
• 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: 19498500
• Report Number: 1037905-2024-00319
• Device Sequence Number: 6735162
• Product Code: ODC
• UDI-Device Identifier: 00827002596832
• UDI-Public: (01)00827002596832(17)250410(10)W4827300
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2025
• Device Catalogue Number: SNAPLOC-O
• Device Lot Number: W4827300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2024
• 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 DREAM WIRE GUIDE.; BOSTON SCIENTIFIC DREAM TOME.; COOK DELTA WIRE GUIDE.; COOK OMNITOME.; ENDOSCOPE, UNKNOWN MAKE AND MODEL.
• Patient Sex: Male