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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001)

Event Date 11/01/1993

Event Type  Death  

Manufacturer Narrative

Usage of device is unknown.Swaroop, v., desai, d., mohandas, k., dhir, v., dave, u., gulla, r., dinshaw, k., deshpande, r.And desai, p.(1994).Dilation of esophageal strictures induced by radiation therapy for cancer of the esophagus.Gastrointestinal endoscopy, 40(3), pp.311-315.This investigation is on-going.Once complete, a follow-up emdr report will be provided.(b)(4).

Event Description

Cook endoscopy was notified of an event that occurred with a savary-gilliard wire guide.Please see below for relevant excerpts of this article.¿one hundred three consecutive patients undergoing esophageal dilation for recurrence of dysphagia after external beam radiation therapy (ebrt), intraluminal radiation therapy (ilrt), or a combination of ebrt and ilrt were included in this study.Patients with strictures having sinus tracts, large ulcers, or deeply excavated ulcers and patients with poor performance status (eastern cooperative oncology group [ecog] scale, grade iv) 4 were excluded.Informed consent was obtained from all patients.All the dilations were performed on an ambulatory basis using intravenous analgesia (pentazocine 15 to 30 mg).The dilations were performed using savary-gilliard dilators and guide wires (wilson cook inc., winston-salem, n.C.).The guide wire was placed by three different techniques: (1) endoscopy only, (2) fluoroscopy only, or (3) a combination of endoscopy and fluoroscopy.Dilation without fluoroscopy was restricted to patients with strictures of the upper or middle third of the esophagus in whom pre-dilation assessment had excluded the presence of skip lesions, long tortuous strictures, deep ulcers, blind sinus tracts, hiatal hernia, and deviation of the luminal axis.The complications included continuous severe pain without perforation in 7 patients, esophageal perforation in 1, suspected esophageal/gastric perforation in 1 [ subject of this report].Both perforations and the tracheo-esophageal fistula developed in patients in whom dilation was performed using combined fluoroscopy and endoscopy.One patient with a very hard stricture experienced severe epigastric pain for half an hour after dilation to 8 mm and was sent home after 6 hours' observation.She died suddenly, 6 hours later, probably as a result of esophageal or gastric perforation [subject of this report]." it was not published in the article if a section of the device remained inside the patient's body.The patient experienced severe epigastric pain for half an hour after dilation and was then sent home after 6 hours' observation.The patient died suddenly, 6 hours later from a suspected esophageal or gastric perforation.

Event Description

Cook endoscopy was notified of an event that occurred with a savary-gilliard wire guide.Please see below for relevant excerpts of this article.¿one hundred three consecutive patients undergoing esophageal dilation for recurrence of dysphagia after external beam radiation therapy (ebrt), intraluminal radiation therapy (ilrt), or a combination of ebrt and ilrt were included in this study.Patients with strictures having sinus tracts, large ulcers, or deeply excavated ulcers and patients with poor performance status (eastern cooperative oncology group [ecog] scale, grade iv) 4 were excluded.Informed consent was obtained from all patients.All the dilations were performed on an ambulatory basis using intravenous analgesia (pentazocine 15 to 30 mg).The dilations were performed using savary-gilliard dilators and guide wires (wilson cook inc., winston-salem, n.C.).The guide wire was placed by three different techniques: (1) endoscopy only, (2) fluoroscopy only, or (3) a combination of endoscopy and fluoroscopy.Dilation without fluoroscopy was restricted to patients with strictures of the upper or middle third of the esophagus in whom pre-dilation assessment had excluded the presence of skip lesions, long tortuous strictures, deep ulcers, blind sinus tracts, hiatal hernia, and deviation of the luminal axis.The complications included continuous severe pain without perforation in 7 patients, esophageal perforation in 1, suspected esophageal/gastric perforation in 1 [ subject of this report].Both perforations and the tracheo-esophageal fistula developed in patients in whom dilation was performed using combined fluoroscopy and endoscopy.One patient with a very hard stricture experienced severe epigastric pain for half an hour after dilation to 8 mm and was sent home after 6 hours' observation.She died suddenly, 6 hours later, probably as a result of esophageal or gastric perforation [subject of this report]." it was not published in the article if a section of the device remained inside the patient's body.The patient experienced severe epigastric pain for half an hour after dilation and was then sent home after 6 hours' observation.The patient died suddenly, 6 hours later from a suspected esophageal or gastric perforation.

Manufacturer Narrative

Usage of device is unknown.Swaroop, v., desai, d., mohandas, k., dhir, v., dave, u., gulla, r., dinshaw, k., deshpande, r.And desai, p.(1994).Dilation of esophageal strictures induced by radiation therapy for cancer of the esophagus.Gastrointestinal endoscopy, 40(3), pp.311-315.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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.The instructions for use include the following potential complications "potential complications associated with upper gastrointestinal endoscopy and esophageal dilation include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression, or arrest, cardiac arrhythmia or arrest.Prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection 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.

• 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
• MDR Report Key: 9216297
• MDR Text Key: 176331283
• Report Number: 1037905-2019-00631
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK SAVARY GILLIARD DILATOR
• Patient Outcome(s): Death