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

Catalog Number HBD-W-18-19-20

Device Problems Hole In Material (1293); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook ds-60cc-s dilation syringe was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, inflation of the balloon was attempted.The balloon would not hold pressure and leakage was observed from a hole at the distal end of the balloon material.A visual examination of the catheter showed a kink at approximately 129.4 cm from the distal end.During deflation, the balloon deflated, however due to the condition of the device, a further evaluation could not be performed.The wire guide associated with this device was included in the return of the device.A terumo 25 ml syringe was also included in the return of the device.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.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, endoscope position 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.A hole in the balloon material can occur if inadequate lubricant is applied prior to advancement through the endoscope.The instructions for use say: ¿apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and balloon preservation.A hole in the balloon material can occur if inadequate negative pressure is applied.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.A hole in the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope.The instructions for use contain the following precaution: ¿do not pre-inflate the balloon." the instructions for use also contain the following precaution: ¿maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically.¿ another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in a failure of the balloon material.The user indicated that they experienced problems during deflation and a strong force was used to remove the balloon.The instructions for use state: ¿to deflate balloon, apply negative pressure and remove all fluid from balloon while observing balloon endoscopically.¿ the instructions for use caution the user: ¿caution: a compromised balloon may prohibit removal from endoscope accessory channel.Removal of endoscope along with compromised balloon may be required.¿ prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual inspection and functional testing to ensure device integrity.The functional tests consist of a flow and leak test.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: 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 the compromised balloon was pulled from the endoscope rather than the endoscope and balloon simultaneously removed, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.A patient underwent endoscopic balloon dilation for gastrointestinal tract [esophagus and duodenum].After first inflation, the balloon would not be removed from the endoscope due to deflation failure.Therefore, it was pulled from the endoscope with strong force, and the balloon broke.Another device was used to complete the procedure.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook ds-60cc-s dilation syringe was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, inflation of the balloon was attempted.The balloon would not hold pressure and leakage was observed from a hole at the distal end of the balloon material.A visual examination of the catheter showed a kink at approximately 129.4 cm from the distal end.During deflation, the balloon deflated, however due to the condition of the device, a further evaluation could not be performed.The wire guide associated with this device was included in the return of the device.A terumo 25 ml syringe was also included in the return of the device.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.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, endoscope position 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.A hole in the balloon material can occur if inadequate lubricant is applied prior to advancement through the endoscope.The instructions for use say: ¿apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and balloon preservation.A hole in the balloon material can occur if inadequate negative pressure is applied.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.A hole in the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope.The instructions for use contain the following precaution: ¿do not pre-inflate the balloon." the instructions for use also contain the following precaution: ¿maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically.¿ another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in a failure of the balloon material.The user indicated that they experienced problems during deflation and a strong force was used to remove the balloon.The instructions for use state: ¿to deflate balloon, apply negative pressure and remove all fluid from balloon while observing balloon endoscopically.¿ the instructions for use caution the user: ¿caution: a compromised balloon may prohibit removal from endoscope accessory channel.Removal of endoscope along with compromised balloon may be required.¿ based on the additional information provided, the user indicated that the 25 ml syringe returned was used as a combination device with another 25 ml inflation device to inflate the balloon.The instructions for use advise the user: "attach the balloon to a 60ml (cc) inflation device with gauge to monitor balloon pressure." prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual inspection and functional testing to ensure device integrity.The functional tests consist of a flow and leak test.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: 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 the compromised balloon was pulled from the endoscope rather than the endoscope and balloon simultaneously removed, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.A patient underwent endoscopic balloon dilation for gastrointestinal tract [esophagus and duodenum].After first inflation, the balloon would not be removed from the endoscope due to deflation failure.Therefore, it was pulled from the endoscope with strong force, and the balloon broke.Another device was used to complete the procedure.The following information was received on 03/27/2017: the returned syringe (another manufacturer's 25 ml syringe) was used as a combined device [used with the device].Saline was used with contrast media [for inflation].

• 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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6411145
• MDR Text Key: 70178830
• Report Number: 1037905-2017-00118
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)191114(10)W3796137
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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-18-19-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2017
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS GIF ENDOSCOPE, UNKNOWN MODEL