MAUDE Adverse Event Report: COOK ENDOSCOPY ECLIPSE TTC WIRE GUIDED BALLOON DILATOR; KNQ, DILATOR, ESOPHAGEAL

Catalog Number	ECL-12X5.5
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook quantum biliary inflation device, qbid-1, acrobat¿ calibrated tip wire guide, acro-35-450.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.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 additional information provided from the user indicated that the balloon was inflated using a qbid (quantum biliary inflation device) and was unable to inflate/deflate as intended.The qbid inflation device has a 20 cc syringe which is incompatible with the dilation balloon and cannot be used to inflate it.The instructions for use advise the user "attach the balloon to a 60 ml (cc) inflation device with gauge to monitor balloon pressure".This is the most likely cause for the reported observation.Prior to distribution, all eclipse ttc wire guided balloon 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.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that an incompatible inflation device was used with this 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.
Event or Problem Description
During an esophageal dilation procedure, the physician used a cook eclipse ttc wire guided balloon dilator.The user advanced device along wire guide into the middle section of the esophagus and began to inflate it.The balloon failed to inflate.The balloon was found leaking under endoscopic visualization.The user withdrew the device and replaced it with a new one to finish the procedure.
Additional Manufacturer Narrative
Concomitant medical products: cook quantum biliary inflation device, qbid-1.Acrobat¿ calibrated tip wire guide, acro-35-450.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook dilation syringe (ds-60cc-s) was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, the balloon was inflated with water.The balloon would not hold pressure and water was seen leaking from a pinhole at the proximal end of the balloon.A visual examination of the catheter showed kinks at 9.6 cm, 10.2 cm, 81.2 cm and 147 cm from the distal end.The pre-loaded stylet wire was included in the return of the device.No portion of the device appeared to be 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 conclusion: the additional information provided from the user indicated that the balloon was inflated using a qbid (quantum biliary inflation device) and was unable to inflate/deflate as intended.The qbid inflation device has a 20 cc syringe which is incompatible with the dilation balloon and cannot be used to inflate it.The instructions for use advise the user "attach the balloon to a 60 ml (cc) inflation device with gauge to monitor balloon pressure." this is the most likely cause for the reported observation.Prior to distribution, all eclipse ttc wire guided balloon 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.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that an incompatible inflation device was used with this 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.
Additional Manufacturer Narrative
This report is being sent to correct a quote in the previously sent investigation conclusion.Concomitant medical products: cook quantum biliary inflation device, qbid-1; acrobat¿ calibrated tip wire guide, acro-35-450.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook dilation syringe (ds-60cc-s) was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, the balloon was inflated with water.The balloon would not hold pressure and water was seen leaking from a pinhole at the proximal end of the balloon.A visual examination of the catheter showed kinks at 9.6 cm, 10.2 cm, 81.2 cm and 147 cm from the distal end.The pre-loaded stylet wire was included in the return of the device.No portion of the device appeared to be 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 conclusion: the additional information provided from the user indicated that the balloon was inflated using a qbid (quantum biliary inflation device) and was unable to inflate/deflate as intended.The qbid inflation device has a 20 cc syringe which is incompatible with the dilation balloon and cannot be used to inflate it.The instructions for use advise the user "this device is used in conjunction with the q.I.D.Or manometer and fluid filled syringe." the q.I.D.Is recommended to be used with this device because it has a 60 cc syringe.The instructions for use also advise the user: "fill inflation device with a minimum of 40 ml and a maximum of 50 ml of fluid by depressing i/d button while simultaneously grasping and pulling back on p/d knob." use of an incorrect inflation device is the most likely cause for the reported observation.Prior to distribution, all eclipse ttc wire guided balloon 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.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that an incompatible inflation device was used with this 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.
Event or Problem Description
During an esophageal dilation procedure, the physician used a cook eclipse ttc wire guided balloon dilator.The user advanced device along wire guide into the middle section of the esophagus and began to inflate it.The balloon failed to inflate.The balloon was found leaking under endoscopic visualization.The user withdrew the device and replaced it with a new one to finish the procedure.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: ECLIPSE TTC WIRE GUIDED BALLOON DILATOR
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6731348
• Report Number: 1037905-2017-00490
• Device Sequence Number: 856033
• Product Code: KNQ
• UDI-Device Identifier: 00827002256309
• UDI-Public: (01)00827002256309(17)180423(10)W3559696
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2018

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 Catalogue Number: ECL-12X5.5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2017
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/08/2017; 06/15/2018
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/25/2017; 07/05/2018
• 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 GIFQ260J ENDOSCOPE
• Patient Age: 63 YR
• Patient Weight: 60