MAUDE Adverse Event Report: COOK ENDOSCOPY QUANTUM TTC BILIARY BALLOON DILATOR; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number QBD-6X3

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

During a balloon dilation procedure, the physician used a cook quantum ttc biliary balloon dilator.The user detected the balloon leaking during the procedure.It was reported that the device was being used in the biliary tree.There was no reportable information at this time.New information was received on 09/10/2021 indicating that the balloon was being used to dilate the duodenal papilla when it leaked.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

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.Our laboratory evaluation of the product said to be involved confirmed the report.The balloon was returned with no damage/kinks/bends in the catheter.The balloon was visually examined and it was noted that the balloon had a ruptured/split down the middle of the balloon material.No other anomalies were noted 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 information provided indicated that negative pressure was not applied to the balloon prior to advancement down the endoscope accessory channel.The ifu states: "to deflate the balloon, apply negative pressure to the balloon dilator.Note: the indicator on the pressure gauge should be in the vacuum portion during deflation." "maintain negative pressure and observe the balloon for complete deflation." a leakage in the balloon can also occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel.Prior to distribution, all quantum ttc biliary balloon dilator are subjected to a visual inspection and functional testing 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.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 negative pressure was not applied, 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: QUANTUM TTC BILIARY BALLOON DILATOR
• Type of Device: FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12598594
• MDR Text Key: 284016864
• Report Number: 1037905-2021-00560
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002226552
• UDI-Public: (01)10827002226552(17)240224(10)W4441641
• Combination Product (y/n): N
• PMA/PMN Number: K171223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 10/08/2021

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: 02/24/2024
• Device Catalogue Number: QBD-6X3
• Device Lot Number: W4441641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK METII-35-480 WIRE GUIDE; OLYMPUS DUODENOSCOPE, UNKNOWN MODEL