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

Catalog Number	HBD-W-18-19-20
Medical Device Problem Codes	Crack (1135); Product Quality Problem (1506); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report as it was described and confirmed a crack in the catheter.A functional test could not be performed on the balloon because a crack was observed in the catheter.During our laboratory evaluation, the balloon was lubricated and attempted to be advanced down an olympus gif-q20 endoscope with a 2.8 mm channel.Difficulty was experienced while advancing the balloon.A visual examination of the catheter showed a crack approximately 23 cm from the distal end.A kink was also observed approximately 115.5 cm from the distal end.A laboratory meeting was conducted with members of production to investigate advancement difficulty through the endoscope accessory channel.An examination of the area between the purple tubing and blue catheter showed the absence of glue.It was confirmed that this could have contributed to advancement difficulty of the balloon through the endoscope accessory channel.The lot number w4046361 was researched to check if any product was in our possession.All product from this lot had been shipped out to the customer.Additionally, the sub assembly lot number involved was used to determine if there were any finished goods lots that were in our possession.All product from this sub assembly lot had been shipped out to the customer.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 user indicated difficulty during advancement of the balloon.During our laboratory investigation, difficulty with advancement was confirmed.It was also discovered that there was absence of glue at the area between the purple tubing and the catheter which could have contributed to the advancement difficulty.This is the root cause for the reported observation.The manufacturing instruction ensures that there is adhesive present between the purple tubing and the distal end of the blue catheter.If the purple tubing does not remain attached to the blue catheter, this will be considered nonconforming.The additional information provided indicated the balloon dilator did not receive lubrication prior to advancement through the endoscope.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.During our laboratory investigation it was also observed that the catheter was cracked.Damage to the catheter can occur if the device experiences excessive pressure, which could have occurred while the users attempted to pass the device into the endoscope.Prior to distribution, all hercules 3 stage wire guided 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: 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 lubrication was not applied to the device, 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, the physician used a cook hercules 3 stage wireguided balloons esophageal-pyloric-colonic.The device would not fit down the endoscope channel.They switched from an olympus q190 endoscope to an olympus q180 endoscope and still had the same problem (2.8 mm channel size for both endoscopes).This problem occurred with three (3) different devices [each from different lots] in the same case.They went to a smaller sized balloon, and it was successful.They successfully finished the case by dilating up to 18 mm.There was no reportable information at this time.The device was received and evaluated on 19-jun-2018 and was found to have a crack in the catheter.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
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report as it was described and confirmed a crack in the catheter.A functional test could not be performed on the balloon because a crack was observed in the catheter.During our laboratory evaluation, the balloon was lubricated and attempted to be advanced down an olympus gif-q20 endoscope with a 2.8 mm channel.Difficulty was experienced while advancing the balloon.A visual examination of the catheter showed a crack approximately 23 cm from the distal end.A kink was also observed approximately 115.5 cm from the distal end.A laboratory meeting was conducted with members of production to investigate advancement difficulty through the endoscope accessory channel.An examination of the area between the purple tubing and blue catheter showed the absence of glue.It was confirmed that this could have contributed to advancement difficulty of the balloon through the endoscope accessory channel.The lot number w4046361 was researched to check if any product was in our possession.All product from this lot had been shipped out to the customer.Additionally, the sub assembly lot number involved was used to determine if there were any finished goods lots that were in our possession.All product from this sub assembly lot had been shipped out to the customer.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 user indicated difficulty during advancement of the balloon.During our laboratory investigation, difficulty with advancement was confirmed.It was also discovered that there was absence of glue at the area between the purple tubing and the catheter which could have contributed to the advancement difficulty.This is the root cause for the reported observation.The manufacturing instruction ensures that there is adhesive present between the purple tubing and the distal end of the blue catheter.If the purple tubing does not remain attached to the blue catheter, this will be considered nonconforming.The additional information provided indicated the balloon dilator did not receive lubrication prior to advancement through the endoscope.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.During our laboratory investigation it was also observed that the catheter was cracked.Damage to the catheter can occur if the device experiences excessive pressure, which could have occurred while the users attempted to pass the device into the endoscope.Prior to distribution, all hercules 3 stage wire guided 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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 lubrication was not applied to the device, 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, the physician used a cook hercules 3 stage wireguided balloons esophageal-pyloric-colonic.The device would not fit down the endoscope channel.They switched from an olympus q190 endoscope to an olympus q180 endoscope and still had the same problem (2.8 mm channel size for both endoscopes).This problem occurred with three (3) different devices [each from different lots] in the same case.They went to a smaller sized balloon, and it was successful.They successfully finished the case by dilating up to 18 mm.There was no reportable information at this time.The device was received and evaluated on 19-jun-2018 and was found to have a crack in the catheter.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: 7687387
• Report Number: 1037905-2018-00314
• Device Sequence Number: 13611705
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)210329(10)W4046361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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: 03/29/2021
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W4046361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/07/2018
• 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 Q180 ENDOSCOPE, OLYMPUS Q190 ENDOSCOPE