MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC STANDARD WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	THSF-35-400
Medical Device Problem Codes	Accessory Incompatible (1004); Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Our evaluation of the product said to be involved confirmed the report.The coil spring has uncoiled and both the flat and safety wires have broken, both segments remain attached by the uncoiled core wire.The core wire began uncoiling 78.5cm from the distal tip of the wire guide.The uncoiled segment stretched from 78.5cm to 186.3cm from the distal tip.A bend was noted 206.0cm to 220.8cm, 263.4cm, and 382.6cm from the distal tip.The total length of the wire guide was has extended to 529.4cm due to the stretched coil spring and broken flat and safety wires.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 product said to be involved confirmed the report.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.In the report it states the wire guide was left in place during current application, the ifu states: "remove this wire guide before applying electrical current." prior to distribution, all standard wire guides 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 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.Additional comments: based on the information provided that the wire guide was left in place during current application, 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 standard wire guide.It was initially reported that when performing a wire exchange, the coil of the wire became unspooled.As a result, the entire wire became stretched further.A new device (lot number unknown) was opened and used to complete the intended procedure successfully.There was no reportable information at this time.Additional information received on 17 apr 2024: it [coating damage] was on patient end [when] it malfunctioned.[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: STANDARD WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 19287305
• Report Number: 1037905-2024-00253
• Device Sequence Number: 12672702
• Product Code: OCY
• UDI-Device Identifier: 00827002138155
• UDI-Public: (01)00827002138155(17)270123(10)W4804579
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/10/2024

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: THSF-35-400
• Device Lot Number: W4804579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: OLYMPUS ENDOSCOPE, UNKNOWN MODEL
• Patient Sex: Unknown