MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SAVARY-GILLIARD WIRE GUIDE; KNQ, DILATOR, ESOPHAGEAL

Catalog Number SGW-200-SD-D

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation of Esophagus (2399)

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the used returned product confirmed the report of a bend/kink in the wire.The returned wire guide was bent in the coiled wire section near the transition from the rigid section of the wire to the flexible coiled section of the wire.The bend/kink was approximately a 70° angle.The stylet wire section of the wire guide was not bent, kinked, or damaged.There was no tissue found in the returned device.No other information can be determined from 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: our investigation confirmed a bend at the tip of the device.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 possible contributing factor for a kink is if the flexible tip of the sgw [savary-gilliard wire guide] is not positioned correctly and monitored fluoroscopically.The instructions for use direct the user "introduce the device, floppy tip first, into the channel of the endoscope and advance until it is endoscopically visualized well beyond the tip of the scope." the user is further instructed "when the wire guide is in position well beyond the strictured area, slowly begin to withdraw the endoscope.Caution: continuous fluoroscopic monitoring of the wire guide is essential in order to ensure it remains in the proper position." prior to distribution, all savary-gilliard 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.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 procedure, the physician used a cook savary-gilliard wire guide.It was reported that the device was used to dilated esophagus.Upon pulling wire from patient's stomach, it was noted that the wire had broken/bent at almost 90 degrees, exposing sharp edges.The patient was found to have a tear in his esophagus that required clipping to close.Upon further inspection, it was noted there was tissue logged in the bend where the wire had broken.The patient was recovered and discharged home, no further interventions were required.A section of the device did not remain inside the patient¿s body.The patient required clipping due to an esophageal tear.According to the initial reporter, the patient recovered and was discharged home, no further interventions were required.

• Brand Name: SAVARY-GILLIARD WIRE GUIDE
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• 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: 16732142
• MDR Text Key: 313747268
• Report Number: 1037905-2023-00173
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002572802
• UDI-Public: (01)10827002572802(17)260103(10)W4670075
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGW-200-SD-D
• Device Lot Number: W4670075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• 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
• Treatment: ENDOSCOPE, MAKE AND MODEL UNKNOWN.
• Patient Outcome(s): Required Intervention