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

Catalog Number HBD-W-10-11-12

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report.There are several kinks and a crack in the catheter approximately 95 cm from the proximal end.In order to test the balloon the catheter was cut and the balloon attached to a 60 cc syringe and an inflation handle.When inflating the balloon, the balloon ruptured at approximately 5 atm.No leaks were observed prior to the balloon failure.No part of the device is missing.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 conclusions: 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.The instructions for use direct the user to apply negative pressure to the balloon to facilitate passage through the endoscope.The application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.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 catheter preservation.The instructions for use state: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." kinks and/or bends and/or cracks in the catheter can occur if the device experiences excessive pressure during use and/or general handling.The instructions for use for this product line advise the user to advance the device through the accessory channel in short increments.This activity will aid in device preservation.Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual inspection and functional testing 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.Investigation evaluation: our evaluation of the returned device confirmed the report.There are several kinks and a crack in the catheter approximately 95 cm from the proximal end.In order to test the balloon the catheter was cut and the balloon attached to a 60 cc syringe and an inflation handle.When inflating the balloon, the balloon ruptured at approximately 5 atm.No leaks were observed prior to the balloon failure.No part of the device is missing.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 conclusions: 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.The instructions for use direct the user to apply negative pressure to the balloon to facilitate passage through the endoscope.The application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.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 catheter preservation.The instructions for use state: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." kinks and/or bends and/or cracks in the catheter can occur if the device experiences excessive pressure during use and/or general handling.The instructions for use for this product line advise the user to advance the device through the accessory channel in short increments.This activity will aid in device preservation.Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual inspection and functional testing 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.

Event Description

During an endoscopy procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The outer catheter was torn.

• 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: 5144015
• MDR Text Key: 28042778
• Report Number: 1037905-2015-00433
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K061937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/17/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-10-11-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/17/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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