MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL

Catalog Number HBD-W-15-16.5-18

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: izasa microport d-pulse inflation device.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.The device history record for the lot number said to be involved could not be reviewed because a lot number was not provided.Investigation conclusion: the additional information provided indicated that an izasa microport d inflation device was used to inflate the balloon.The microport d inflation device has a 30 cc syringe which is incompatible with the dilation balloon and should not be used to inflate it.The instructions for use advise the user "attach the balloon to a 60 ml (cc) inflation device with gauge to monitor balloon pressure." use of the device with an incompatible inflation device is the most likely cause for the reported observation.The user also indicated that negative pressure and lubrication were not applied to the balloon prior to advancement.This is another likely cause for the reported observation.A contributing factor to a leakage in the balloon material is failure to apply negative pressure and lubrication to the balloon prior to advancement through the endoscope.The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the device." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The application of lubrication will aid in endoscopic advancement and balloon preservation.The instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a visual examination 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.Additional comments regarding this report: based on the information provided that negative pressure and lubrication were not applied prior to advancing the balloon into the endoscope, and an incompatible inflation device was used, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an esophageal dilation procedure, the physician used a cook hercules 3 stage wire guided balloon esophageal-pyloric-colonic.When using the product, the balloon could not be inflated.When removing the endoscope, they saw that something was missing from the main catheter.The following information was provided 31-may-2019: they were doing a dilatation on the esophagus with a pentax gastroscope.When they arrived to the first atm of [pressure] with the inflation device; [it was] noted that they suddenly [lost pressure].They removed the endoscope from the patient with the balloon partially deflated and saw, in the union of the balloon with the catheter, a gap.For this gap, they supposed the balloon lose the liquid pression [sic] [because of this gap, they supposed the balloon lost liquid pressure], so they cut the catheter of the device in order to retrieve it from the working channel of the endoscope and continued the [procedure] with another cook balloon.The following information was provided 10-jun-2019: they removed the endoscope with the balloon, and outside the patient [they] cut the catheter for [removal from] the working channel.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

During an esophageal dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.When using the product, the balloon could not be inflated.When removing the endoscope, they saw that something was missing from the main catheter.The following information was provided on (b)(6) 2019: they were doing a dilatation on the esophagus with a pentax gastroscope.When they arrived to the first atm of [pressure] with the inflation device; [it was] noted that they suddenly [lost pressure].They removed the endoscope from the patient with the balloon partially deflated and saw, in the union of the balloon with the catheter, a gap.For this gap, they supposed the balloon lose the liquid pression [sic] [because of this gap, they supposed the balloon lost liquid pressure], so they cut the catheter of the device in order to retrieve it from the working channel of the endoscope and continued the [procedure] with another cook balloon.The following information was provided on (b)(6) 2019: they removed the endoscope with the balloon, and outside the patient [they] cut the catheter for [removal from] the working channel.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Continued from section d11: izasa microport d-pulse inflation device.Investigation evaluation: an evaluation of the returned device confirmed the report.The only portion of the device included in the returned was the detached balloon material from the catheter.The catheter portion was missing and not included in the return, which made it difficult to perform a complete evaluation.Also included in the returned was a sealed microport d-pulse inflation device with a 30 cc syringe.The balloon material was observed to be bunched up and the purple tubing appears to have been cut in one location from the rest of the device.A laboratory meeting was conducted with members of production to further investigate why the balloon material had detached from the rest of the device.During the laboratory meeting, a close visual examination of the balloon material was performed to determine the presence or absence of glue at the proximal balloon joint.It was first noted there was accumulation of contrast in the balloon material and at the joint, therefore the balloon material was flushed with water to remove contrast.On removal of contrast, the evidence of glue was confirmed at the proximal balloon joint.Although there was evidence of glue, it was unable to be confirmed if there was sufficient glue without the catheter portion of the device.The edge of the proximal balloon joint was also observed to be curled in several areas, which does not represent the condition of the device at the time of manufacture.A lot of pressure appears to have been applied to the device and due to the curling observed and the bunched up condition of the balloon material when received, it was unable to be determined why the balloon detached from the catheter portion of the device.The device history record for the lot number said to be involved could not be reviewed because a lot number was not provided.Investigation conclusion: the additional information provided indicated that an izasa microport d inflation device was used to inflate the balloon.The microport d inflation device has a 30 cc syringe which is incompatible with the dilation balloon and should not be used to inflate it.The instructions for use advise the user "attach the balloon to a 60 ml (cc) inflation device with gauge to monitor balloon pressure." use of the device with an incompatible inflation device is the most likely cause for the reported observation.The user also indicated that negative pressure and lubrication were not applied to the balloon prior to advancement.This is another likely cause for the reported observation.A contributing factor to a leakage in the balloon material is failure to apply negative pressure and lubrication to the balloon prior to advancement through the endoscope.The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the device." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The application of lubrication will aid in endoscopic advancement and balloon preservation.The instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a visual examination 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.Additional comments regarding this report: based on the information provided that negative pressure and lubrication were not applied prior to advancing the balloon into the endoscope, and an incompatible inflation device was used, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8724151
• MDR Text Key: 152204573
• Report Number: 1037905-2019-00341
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTAX GASTROSCOPE - UNKNOWN MODEL