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

Catalog Number QBD-10X3

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

During sphincteroplasty, the physician used a cook quantum ttc biliary balloon dilator.It was reported [that the] user detected the balloon was leaking during procedure.User then changed to another brand of similar device to complete 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.

Manufacturer Narrative

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: 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.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 to the balloon prior to advancement down the endoscope accessory channel, 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.

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.A functional test was performed.A cook quantum biliary inflation device (qbid-1) was filled with water and attached to the balloon inflation port and negative pressure was applied to the balloon.After applying negative pressure, the balloon was inflated and a leak could be seen coming from a pinhole near the middle section of the balloon material.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.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 leak was observed coming from a pinhole in the balloon material of the returned device.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 to the balloon prior to advancement down the endoscope accessory channel, 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): 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: 16286884
• MDR Text Key: 308675200
• Report Number: 1037905-2023-00044
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002226576
• UDI-Public: (01)10827002226576(17)241101(10)W4532020
• Combination Product (y/n): N
• PMA/PMN Number: K171223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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 Catalogue Number: QBD-10X3
• Device Lot Number: W4532020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - OLYMPUS 290