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 Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: boston scientific alliance inflation handle.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.A balloon material pinhole can occur if inadequate lubricant is applied prior to advancement through the endoscope.The instructions for use say: "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.A balloon material pinhole can occur if inadequate negative pressure is applied.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.A balloon material pinhole 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 contain the following precaution: ¿maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in a failure of the balloon material.The instruction for use direct the user by saying: "balloon can be inflated to three distinct diameters, as indicated on package and catheter tag." 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.The functional tests consist of a flow and leak test.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 an esophageal dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.There was a pinhole noted in the balloon when inflating.The physician opened a new balloon to complete the procedure.

Manufacturer Narrative

Concomitant medical products: boston scientific alliance inflation handle.Investigation evaluation: our evaluation of the returned device confirmed the report.During a functional evaluation, the balloon was inflated with water using a 60 cc syringe and an inflation handle.The balloon inflated and a small and steady stream of water exited the balloon at the location of the small hole present in the balloon material.The hole is located near the distal end of the dilation balloon.No part of the device is missing.A visual inspection of the device confirmed no kinks or bends.The wire guide was not 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 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.A balloon material pinhole can occur if inadequate lubricant is applied prior to advancement through the endoscope.The instructions for use say: "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.A balloon material pinhole can occur if inadequate negative pressure is applied.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.A balloon material pinhole 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 contain the following precaution: ¿maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in a failure of the balloon material.The instructions for use direct the user by saying: "balloon can be inflated to three distinct diameters, as indicated on package and catheter tag." 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.The functional tests consist of a flow and leak test.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.

• 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: 6181362
• MDR Text Key: 62708140
• Report Number: 1037905-2016-00503
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)190929(10)W3778319
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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: (B)(4) ENDOSCOPE (UNKNOWN MODEL)