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

Model Number	G51795
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook quantum inflation device - qid-1.Occupation: non-healthcare provider.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 a leakage was observed from a rupture in the balloon material.The pre-loaded wire guide was 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: the additional information provided indicated that the balloon did not receive negative pressure nor lubrication prior to advancement through the endoscope accessory channel.Failure to apply negative pressure and lubrication is against the instructions for use for the device.This is the most likely cause for the reported observation.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 instructions for use also 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.¿ 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 wireguided balloons esophageal-pyloric-colonic are subjected to a visual examination 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 the balloon did not receive negative pressure nor lubrication and that the device was used on a pediatric patient, 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 a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon burst while [completing the] dilation, spreading the contrast medium inside it [the esophagus].The balloon was removed and it was replaced with another one with the next measure.While performing an esophagoscopy, a esophageal dilation with the 10-11-12 balloon was made, but it presented a rupture, leading to a contrast medium spill.The doctor decide to replace the balloon with a 13-14-15 with some difficulties.There were no additional complications with the patient.Additional information was received 02-may-2019: a seven (7) months old patient, who because of a tumor, had surgical resection and subsequent anastomosis with prolene sutures.The anatomic alteration generated stenosis and diminished the esophagus light by 99% which caused the difficult access of the device.The patient had an altered anatomy due to a previous intervention.When the anatomy is altered the device's access is always hard.The anatomic conditions of the patient make the product access difficult.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.

• 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: 8628599
• Report Number: 1037905-2019-00266
• Device Sequence Number: 11274859
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)210320(10)W4044976
• 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
• Report Date (Section B): 04/26/2019

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: 03/20/2021
• Device Model Number: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4044976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/21/2019
• 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 160 ENDOSCOPE
• Patient Age: 7 MO