MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION BILIARY DILATION BALLOON

Model Number G31532

Device Problems Leak/Splash (1354); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

During an endoscopic papillary balloon dilation, the physician used a cook fusion biliary dilation balloon.It was reported [that] the user attempted to inflate the balloon at the papilla for dilatation, but the balloon would not inflate.Leakage of contrast media from balloon was observed.There is no information how the planned procedure finished after this event occurred.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.

Manufacturer Narrative

The device was received at the time of report submission and the investigation is in progress.A follow up emdr will be sent.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.A non-cook inflation device was also received in the return.Our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed on the returned device.A cook quantum biliary inflation device qbid-1 was filled with water and attached to the balloon inflation port.Negative pressure was applied to the balloon.After applying negative pressure, the balloon was inflated with water.The balloon would not hold pressure and a leakage was seen from a hole in the balloon material.A visual examination of the catheter did not show any kinks or bends.The distal and proximal gold bands under the balloon material were observed to be smooth.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 balloon was found to be leaking on the returned device.The information provided indicates that the device was used in the duodenal papilla.Use of the device in the duodenal papilla is against the intended use and a likely cause for the reported observation.The intended use states: ¿this device is used to dilate strictures of the biliary tree." the instructions for use also advise the user: "do not use this device for any purpose other than the stated intended use." it is also indicated that lubrication was not applied to the balloon prior to advancement through the endoscope accessory channel.This is another likely cause for the reported observation.A contributing factor to balloon leakage is failure to apply lubrication to the balloon prior to advancement through the endoscope.The instructions for use direct the user: "apply a water-soluble lubricant to balloon to allow easier passage through accessory channel." this activity will aid in endoscopic advancement and balloon preservation.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 lubrication was not applied to the balloon prior to advancement through the endoscope accessory channel and device was used in the duodenal papilla, 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.

• Brand Name: FUSION BILIARY DILATION BALLOON
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 14637117
• MDR Text Key: 297735881
• Report Number: 1037905-2022-00276
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00827002315327
• UDI-Public: (01)00827002315327(17)230819(10)W4377200
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

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 Expiration Date: 08/19/2023
• Device Model Number: G31532
• Device Catalogue Number: FS-BDB-10X3
• Device Lot Number: W4377200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• 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: ENDOSCOPE - OLYMPUS / JF-260V