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

Model Number	G51798
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: boston scientific alliance inflation device occupation: non-healthcare professional investigation evaluation: a photo was provided and evaluated.An evaluation of the photo provided confirmed the report.Separation of the plug from the balloon material could be seen at the distal end.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.During a visual examination, it was observed that the balloon protector had been returned on the balloon and moved proximally.A visual examination of the balloon showed that the plug separated from the balloon material at the distal end.The plug remained attached to the purple inner catheter.A visual examination of the catheter showed a kink approximately 18.5 cm from the distal end.The wire guide associated with this device was included in the return of the device.A visual examination of the pre-loaded wire guide showed that the white cap located at the proximal end of the wire guide was missing and not included in the return.A laboratory meeting was conducted with members of production to investigate plug separation from the balloon material at the distal end.During the meeting, it was confirmed that there was evidence of glue present between the balloon neck and plug.A small void was also present at the base of the plug.Per members of production, this did not contribute to separation at the distal balloon joint.The meeting concluded that the device had been manufactured according to specification.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: responses to additional questions indicated that the user used xylocaine as a lubricating agent for the balloon.The user is advised to use a more suitable lubricating agent to lubricate the balloon.The instructions for use direct the user, "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.Responses to additional questions indicated that negative pressure was not applied to the balloon prior to advancement.This is a likely cause for the reported observation.The instructions for use advise 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 instructions for use advise the user: "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." during the manufacturing of the dilation balloon, the distal tip is verified to ensure the balloon joint is glued adequately.This process ensures there are no leakages in the balloon joint.After assembly, the balloon is leak tested to ensure there is no leakage.Prior to distribution, all hercules 3 stage wire guided balloons esophageal-pyloric-colonic are subjected to a leak test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is currently being assessed and a follow up report will be sent.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 xylocaine was used as a lubricating agent and that negative pressure was not applied to the balloon, 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 or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage wire guided balloon esophageal-pyloric-colonic.While performing an esophageal dilation, when the balloon was introduced into the working channel of the endoscope, the doctor saw the defect.The catheter on the distal end came loose and when insufflating, the contrast medium goes out [leaks] and the procedure could not continue.There was no additional complication with the patient.The physician changed the balloon for another manufacturer's device and the procedure continued.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 or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.While performing an esophageal dilation, when the balloon was introduced into the working channel of the endoscope, the doctor saw the defect.The catheter on the distal end came loose and when insufflating, the contrast medium goes out [leaks] and the procedure could not continue.There was no additional complication with the patient.The physician changed the balloon for another manufacturer's device and the procedure continued.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.
Additional Manufacturer Narrative
Boston scientific alliance inflation device.Occupation: non-healthcare professional.Investigation evaluation: a photo was provided and evaluated.An evaluation of the photo provided confirmed the report.Separation of the plug from the balloon material could be seen at the distal end.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.During a visual examination, it was observed that the balloon protector had been returned on the balloon and moved proximally.A visual examination of the balloon showed that the plug separated from the balloon material at the distal end.The plug remained attached to the purple inner catheter.A visual examination of the catheter showed a kink approximately 18.5 cm from the distal end.The wire guide associated with this device was included in the return of the device.A visual examination of the pre-loaded wire guide showed that the white cap located at the proximal end of the wire guide was missing and not included in the return.A laboratory meeting was conducted with members of production to investigate plug separation from the balloon material at the distal end.During the meeting, it was confirmed that there was evidence of glue present between the balloon neck and plug.A small void was also present at the base of the plug.Per members of production, this did not contribute to separation at the distal balloon joint.The meeting concluded that the device had been manufactured according to specification.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: responses to additional questions indicated that the user used xylocaine as a lubricating agent for the balloon.The user is advised to use a more suitable lubricating agent to lubricate the balloon.The instructions for use direct the user, "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.Responses to additional questions indicated that negative pressure was not applied to the balloon prior to advancement.This is a likely cause for the reported observation.The instructions for use advise 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 instructions for use advise the user: "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." during the manufacturing of the dilation balloon, the distal tip is verified to ensure the balloon joint is glued adequately.This process ensures there are no leakages in the balloon joint.After assembly, the balloon is leak tested to ensure there is no leakage.Prior to distribution, all hercules 3 stage wire guided balloons esophageal-pyloric-colonic are subjected to a leak test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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 xylocaine was used as a lubricating agent and that negative pressure was not applied to the balloon, 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.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8531478
• Report Number: 1037905-2019-00215
• Device Sequence Number: 1840337
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)200707(10)W3888034
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: G51798
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W3888034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS 170 ENDOSCOPE.; OLYMPUS 170 ENDOSCOPE.
• Patient Age: 70 YR