MAUDE Adverse Event Report: COOK ENDOSCOPY WILSON-COOK ACHALASIA BALLOON

Catalog Number WCAB-30

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

Patient Problems Perforation (2001); Perforation of Esophagus (2399)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

Patient information: age at time of event: (b)(6) years.Gender: 14 males/10 females.Suspect medical devices: product code: pid.Common name: esophageal dilator balloon with or without electrode sensors.Pma/510 (k): k182895.The investigation is on-going.A follow-up emdr will be sent following the completion of the investigation.Dai, j., shen, y., li, x., gao, y., song, y., & ge, z.(2016).Long-term efficacy of modified retrievable stents for treatment of achalasia cardia.Surgical endoscopy, 30(12), 5295¿5303.(b)(4).

Event Description

Cook endoscopy was notified of this event via a clinical literature article involving two (2) wilson-cook achalasia balloons.This article was published in 2016.Please see below for relevant excerpts of this article.The aim of the study was ¿to investigate the efficacy, safety and optimal duration of placement of modified retrievable metal stents for treatment of achalasia cardia.Patients were randomly divided into groups a (n = 26, modified stents for 3 days), b (n = 26, modified stents for 2 days), c (n = 24, balloon dilation), and d (n = 25, regular stents for 2 days).Clinical symptom scores were recorded at baseline, 6 months, and during long-term follow-up.Esophageal pressure was measured using pneumohydraulic perfusion system (medtronic functional diagnostics a/s,sweden); gastroscopy was performed using olympus gifh260 (olympus medical system co, ltd, tokyo, japan); and sacculus, model wcab-30 (balloon with 30 mm diameter and 8 mm length), was obtained from cook medical co, ltd, indiana, usa.Modified retrievable self expandable nickel-titanium alloy esophageal stents with silica gel membrane were obtained from micro-tech co.(nanjing, china, mtn-se-g-30/70).In group c patients, gastroscope containing the guide wire was used to reach the descending duodenum.Gastroscope was pulled out while retaining the guide wire.The balloon dilation catheter was delivered into esophagus through the guide wire.Balloon was placed in the cardia under radiographic guidance.Then, the balloon was dilated; the catheter was taken out after 3 min.Patients were monitored for complications.Two patients in the group c developed esophageal perforation; they were discharged from the hospital 10 days after surgical repair.Compared to the use of stents, balloon dilation requires shorter time but involves use of greater physical force on the esophageal wall for achieving dilation.It has acute and irregular effect on the muscular layer in the cardia, which predisposes to perforation, scarring and stricture formation.The long-term effect is unsatisfactory and requires repeated dilations.¿ it was not reported within the clinical literature article if a section of the device remained inside the patient¿s body.The patients did require surgical interventions due to these occurrences.According to the article, the two (2) patients experienced esophageal perforations.

Manufacturer Narrative

A.Patient information: age at time of event: 51.46 ± 13.22 years.Gender: 14 males/10 females.D.Suspect medical devices: product code: pid.Common name: esophageal dilator balloon with or without electrode sensors.Pma/510 (k): k182895.Citation: dai, j., shen, y., li, x., gao, y., song, y., & ge, z.(2016).Long-term efficacy of modified retrievable stents for treatment of achalasia cardia.Surgical endoscopy, 30(12), 5295¿5303.Https://doi.Org/10.1007/s00464-016-4879-9.Investigation evaluation: 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.However a device failure was not reported in the article.The article reported occurrences of perforation during dilation of the sphincter.Perforation is a known complication of these types of procedures.The instructions for use includes the following potential complications: "those associated with upper gi endoscopy 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 wilson-cook achalasia balloon are subjected to a visual inspection 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: WILSON-COOK ACHALASIA BALLOON
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12017718
• MDR Text Key: 267141449
• Report Number: 1037905-2021-00253
• Device Sequence Number: 1
• Product Code: PID
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WCAB-30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE, UNKNOWN MAKE OR MODEL.; OLYMPUS GIFH260.
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR