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

Catalog Number HBD-W-18-19-20

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr report is part of the 227 pilot program.Concomitant medical products: boston scientific alliance inflation handle, cook ds-60cc-s syringe.For the one (1) reported event, the device was not returned to cook endoscopy.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.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.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 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.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 direct the user to ensure the balloon is completely visualized and positioned before inflation.The instructions for use contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure.¿ over inflation can cause damage to the balloon dilator.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 damage to the balloon material.Prior to distribution all hercules 3 stage wireguided balloon esophageal-pyloric-colonic dilators 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.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

This report summarizes one (1) malfunction event.A review of the event indicated that during an esophageal stricture dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.This information was provided by the customer to the cook representative: after dilation, when the physician tried to remove the balloon from the endoscope, he felt much resistance.He stopped and removed it [the device] together with the endoscope.When it [the device] is outside of the patient, the physician noticed the connection between balloon and catheter is torn.He tried to inflate the balloon but failed; water leaked from the bottom of the balloon.The one (1) event involved a patient with no consequences.

• 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: 5828900
• MDR Text Key: 50633714
• Report Number: 1037905-2016-00207
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)171119(10)W3501118
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-18-19-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2016
• Date Device Manufactured: 11/19/2014
• 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: OLYMPUS GIF-H180 ENDOSCOPE
• Patient Age: 53 YR