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

Catalog Number SGW-200-SD

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation of Esophagus (2399)

Event Date 04/13/2020

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the 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 stylet wire section of the wire guide had not been bent, kinked, or damaged in any way.The possible lot numbers of the product said to be involved were used to review the device history records.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: 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 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.Placement of the wire guide in the correct location is critical to avoid kinking the wire guide and assuring correct dilation.Specifically, per the instructions for use: "when the wire guide is in position well beyond strictured area." contacting the coil spring end of the wire guide with the dilator may also result in kinking.The instructions for use provides the following caution statement: "caution: continuous fluoroscopic monitoring of wire guide is essential in order to ensure it remains in 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 for the possible lot numbers confirmed that the lots 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 esophageal dilation procedure, the physician used a cook savary-gilliard wire guide.Patient went back to the recovery room and was experiencing pain.Patient had a tear in the esophagus and required surgery.The wire guide was bent at a 45-degree angle.Repair surgery has been completed.Additional information was provided by the customer on (b)(6) 2020: the wire and dilator were removed at the same time.Per the rn in the procedure room, there was not an attempt to pull the wire back through the dilator.A section of the device did not remain inside the patient¿s body.The patient required surgical repairing of an esophageal tear/perforation.The patient is reported to be "doing well".

• Brand Name: SAVARY-GILLIARD WIRE GUIDE
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 10039537
• MDR Text Key: 196938067
• Report Number: 1037905-2020-00204
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGW-200-SD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention