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

Catalog Number HBD-18-19-20

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Use of Device Problem (1670)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

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 was reviewed.The device history record contains a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: the additional information provided indicated that negative pressure and lubrication were not applied to the balloon prior to advancement through the endoscope accessory channel.This is the most likely cause for the reported observation.The instructions for use advise the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." 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 instructions for use advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." the application of lubrication will aid in endoscopic advancement and balloon preservation.Instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." the user indicated that an attempt was made to remove a ruptured balloon from the endoscope.The instructions for use caution the user: "caution: a compromised balloon may prohibit removal from the endoscope accessory channel.Removal of the endoscope along with the compromised balloon may be required." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a visual inspection and functional testing to ensure device integrity.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.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.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 to the balloon prior to advancement through the endoscope accessory channel, 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 an endoscopic procedure, the physician used a cook hercules 3 stage balloon esophageal.A faulty hercules balloon, it was leaking water during insufflation (was not able to fully inflate), and ruptured when pulled out of the endoscope.An incident report has been submitted for this issue, due to we were unable to locate the balloon that was detached from the catheter.The surgeon looked through the gi (gastrointestinal) tract and flushed the endoscope, [but was] unable to find [the balloon].The endoscope used was sent for repair due to uncertainty of the location of the balloon.It is unknown if part of the balloon remained inside of the patient or the endoscope.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

Manufacturer Narrative

Continued from section d11: boston scientific inflation syringe, unknown model.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test could not be performed due to the condition of the returned device.A visual examination of the distal end of the balloon showed that a large portion of the balloon material including the balloon tip had detached and was not included in the return.Only a small portion of the balloon material was present and bunched up on the proximal end.No kinks or bends were observed in the catheter.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.The device history record contains a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: the additional information provided indicated that negative pressure and lubrication were not applied to the balloon prior to advancement through the endoscope accessory channel.This is the most likely cause for the reported observation.The instructions for use advise the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." 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 instructions for use advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." the application of lubrication will aid in endoscopic advancement and balloon preservation.Instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." the user indicated that an attempt was made to remove a ruptured balloon from the endoscope.The instructions for use caution the user: "caution: a compromised balloon may prohibit removal from the endoscope accessory channel.Removal of the endoscope along with the compromised balloon may be required." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a visual inspection and functional testing to ensure device integrity.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.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.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 to the balloon prior to advancement through the endoscope accessory channel, 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

The following was initially reported on 06-dec-2018: "during an endoscopic procedure, the physician used a cook hercules 3 stage balloon esophageal.A faulty hercules balloon, it was leaking water during insufflation (was not able to fully inflate), and ruptured when pulled out of the endoscope.An incident report has been submitted for this issue, due to we were unable to locate the balloon that was detached from the catheter.The surgeon looked through the gi (gastrointestinal) tract and flushed the endoscope, [but was] unable to find [the balloon].The endoscope used was sent for repair due to uncertainty of the location of the balloon." the device was received on 14-dec-2018 and it was observed that a portion of the balloon material and balloon tip were detached and missing.It is unknown if part of the balloon remained inside of the patient or the endoscope.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8138755
• MDR Text Key: 130212711
• Report Number: 1037905-2018-00572
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002319271
• UDI-Public: (01)00827002319271(17)210828(10)W4111859
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: HBD-18-19-20
• Device Lot Number: W4111859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTAX ENDOSCOPE - UNKNOWN MAKE AND MODEL