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

Catalog Number SGW-250-SD-D

Device Problem Material Twisted/Bent (2981)

Patient Problems Perforation of Esophagus (2399); Gastrointestinal Hemorrhage (4476)

Event Date 02/14/2024

Event Type  Injury  

Event Description

During an esophagogastroduodenoscopy, the physician used a cook savary-gilliard wire guide.It was reported [that the] guide wire bent and appeared to puncture the patient's esophagus.Dr.(b)(6) reassessed the area and noted bleeding, so she immediately discontinued the procedure.Patient was monitored continuously by dr.(b)(6), anesthesia providers and nursing staff; remained stable without reported pain and normal vital signs.911 was called and patient was transported to boulder community health.Intervention of some type was required.Images were provided of the device to show the wire guide bent.A section of the device did not remain inside the patient¿s body.The patient required hemostasis intervention of some type due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a red biobag, a lot number was not included with the return.Photos were provided and reviewed.One of the photos provided show the device in a pouch without the bend in the distal end of the wire.The other two photos show the device coiled and bent at the distal end of the wire.Our laboratory evaluation of the product said to be involved confirmed the report.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.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 is not positioned correctly and monitored fluoroscopically.The instructions for use direct the 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 stricture 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.

• 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: 18881807
• MDR Text Key: 337412911
• Report Number: 1037905-2024-00140
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002572819
• UDI-Public: (01)10827002572819(17)261117(10)W4785448
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGW-250-SD-D
• Device Lot Number: W4785448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• 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: UNKNOWN ENDOSCOPE.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female