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

Catalog Number HBD-W-12-13.5-15

Device Problems Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the stylet wire included.During a visual inspection, catheter breakage was determined.There were several breaks in the catheter.The locations of the breaks were 37.8 cm, 54.5 cm, 204 cm, and 223.8 cm from the distal end of the proximal hub.Despite multiple breaks in the catheter, no section of the catheter material appeared to be missing.Due to the condition of the catheter, a functional test on the balloon material was not performed.There appeared to be a white like substance (possibly contrast) constantly on the catheter throughout the length of the device.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 possible contributing factor to balloon material damage is inadequate lubrication of the balloon with a lubricating agent.The instructions for use direct the user to "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.Another possible contributing factor to balloon material damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.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 states, "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until the balloon is completely visualized endoscopically." damage in the catheter can occur if the device experiences excessive pressure during general handling.Prior to distribution, all hercules 3 stage wireguided balloon 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 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.

Event Description

During a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The user applied lubricants such as olive oils to the catheter and the balloon of device and inserted it into an endoscope with 3.2 mm channel for the small intestine.However, advancement in the endoscope was difficult and the catheter kinked, so he replaced it with another hercules 3 stage wireguided balloon esophageal-pyloric-colonic to complete the procedure.The device was received for evaluation on 12/29/2016.It was found during the investigation that the catheter was broken at the distal end.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the stylet wire included.During a visual inspection, catheter breakage was determined.There were several breaks in the catheter.The locations of the breaks were 37.8 cm, 54.5 cm, 204 cm, and 223.8 cm from the distal end of the proximal hub.Despite multiple breaks in the catheter, no section of the catheter material appeared to be missing.Due to the condition of the catheter, a functional test on the balloon material was not performed.There appeared to be a white like substance (possibly contrast) constantly on the catheter throughout the length of the device.During an additional visual inspection of the device performed on 02/23/2017, the balloon appeared to have been partially inflated [prior to being advance down the endoscope].Inside the balloon material appears to be a white substance that is possibly contrast.The distal balloon joint passed a ring gauge inspection, while the proximal end was unable to be tested due to the device being partially inflated.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.Damage to 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 direct the user to ensure the balloon is completely visualized and positioned before inflation.Another possible contributing factor to balloon material damage is inadequate lubrication of the balloon with a lubricating agent.The instructions for use direct the user to "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.An additional possible contributing factor to balloon material damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.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 states, "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until the balloon is completely visualized endoscopically." damage in the catheter can occur if the device experiences excessive pressure during general handling.Prior to distribution, all hercules 3 stage wireguided balloon 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 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 investigation findings that the user pre-inflated 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
• 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: 6270820
• MDR Text Key: 65577304
• Report Number: 1037905-2017-00029
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517967
• UDI-Public: (01)00827002517967(17)190411(10)W3707236
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-12-13.5-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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: FUJIFILM ENDOSCOPE, UNKNOWN MODEL