MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION BILIARY DILATION BALLOON; FGE, CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	FS-BDB-8X3
Medical Device Problem Codes	Hole In Material (1293); Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: boston scientific jagwire 0.035 inch wire guide; boston scientific alliance ii inflation device.Investigation evaluation: our laboratory evaluation of the product said to be involved and the photo provided by the user in the endoscopic view, we were able to confirm the report.A visual examination of the returned device showed no kinks or bends in the catheter.During a functional test, the balloon was inflated with water using a cook quantum biliary inflation device.During inflation, we observed water leaking from a pinhole in the balloon material near the distal end.No portion of the balloon material is missing.No other anomalies were detected with 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.The instructions for use state: ¿this device is used to dilate strictures of the biliary tree." the instructions for use advise the user: "do not use this device for any purpose other than the stated intended use." according to the report the device was used in the papilla, which is against the instructions for use.The additional information provided indicated the balloon did not receive negative pressure prior to advancement through the endoscope.This is the most likely cause for the reported observation.The instructions for use under system preparation states: "create and maintain a vacuum with inflation device.Dilation balloon is now ready for placement through accessory channel of duodenoscope." the additional information provided indicated the balloon did not receive lubrication prior to advancement through the endoscope.This is another likely cause for the reported observation.The instructions for use direct the user to: "apply a water soluble lubricant to balloon to allow easier passage through accessory channel." this activity will aid in endoscopic advancement and balloon preservation.A balloon leakage 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 inflate the balloon prior to introduction into the scope, as this may cause damage to the scope.¿ the instructions for use also contain the following precaution: ¿the entire dilation balloon must be extended beyond the tip of the duodenoscope and be fluoroscopically visualized and positioned before inflation.¿ the instructions for use contain the following warning: ¿do not exceed the recommended balloon inflation pressure as listed on the catheter tag of the dilation balloon.¿ over inflation can cause damage to the balloon dilator, such as a balloon leakage.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 rupture of the balloon material.Prior to distribution, all fusion biliary dilation balloons are subjected to a visual inspection and functional testing to ensure device integrity.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.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 information provided, that the device was used off-label, and that lubrication nor negative pressure were applied, a cook representative has contacted 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 endoscopic papillary balloon dilation (epbd) procedure [against intended use], the physician used a cook fusion biliary dilation balloon.While inflation of the balloon to dilate the papilla, it was noticed that small bubble occurred a lot from the papilla side.It was noticed that the spray of contrast media was observed from proximal side of the balloon.The balloon would not inflate.It was replaced with another of the same device to complete the procedure.

• Brand Name: FUSION BILIARY DILATION BALLOON
• Common Device Name: FGE, CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6396846
• Report Number: 1037905-2017-00100
• Device Sequence Number: 540355
• Product Code: FGE
• UDI-Device Identifier: 00827002315310
• UDI-Public: (01)00827002315310(17)190815(10)W3759723
• Combination Product (Y/N): N
• PMA/510(K) Number: K040800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: FS-BDB-8X3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2017
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/10/2017
• 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 JF-260V ENDOSCOPE