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

Catalog Number SGW-200-SD

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.The report was confirmed based on the three photos provided to aid the investigation.In each of the photos, it can be seen that the wire guide is damaged and severely kinked.The flexible distal tip of the wire appears to have a slight kink in it as well.The entire sgw could not be seen in the pictures provided and no additional details could be determined without return of the complaint device.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.To help prevent difficulties with sgw use, the product instructions for use notes state: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." in addition, step 5 of the instructions state: "generously lubricate dilator with water- soluble lubricant and advance it, under fluoroscopic monitoring, over prepositioned wire guide through strictured area." it is unknown if these activities were performed.As a precaution, select cook medical devices that are currently labeled as reusable devices, will be transitioned to disposable devices.These devices will now be disposable and labeled as intended for single use only.Prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing to ensure device integrity.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, the physician used a cook savary-gilliard wire guide.Per the user, "on friday, (b)(6), we had a complication with a reusable guidewire while dilating a patient¿s esophagus.After the second pass of the savary, the physician met with resistance upon attempting to remove the guidewire.He attempted to remove the guidewire for approximately 40 minutes and determined he may cause more damage and it would likely need to be surgically removed.Ems was called and the patient was intubated to protect her airway.She was transported via ems and she was accompanied to the hospital by a crna and rn.The patient had the guidewire surgically removed and is stable condition at this point.The following was received on 01/17/2020: the savary wire guide was kinked in the patient but not imbedded.It was not stuck in the dilator.There was no perforation but there was laceration of the mucosa.A section of the device did not remain in the patient's body.The patient required surgical removal of the kinked wire guide.The patient is in stable condition.No adverse effects have been reported.

• 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: 9634969
• MDR Text Key: 189648950
• Report Number: 1037905-2020-00038
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR