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-8X3

Device Problems Fracture (1260); Leak/Splash (1354); Off-Label Use (1494)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook quantum ttc biliary balloon dilator.It was reported [that the] user inflated the [dilation] balloon in order to dilate the duodenal papilla but found out the balloon [had] broken, and the pressure of the balloon could not be maintained, and the dilation was insufficient to meet the procedure needs.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 box/pouch from the lot number provided in the report.The label matches the product returned.Two photos were also provided.One photo shows the balloon catheter coiled and deflated and the other photo shows the outer box and labeling confirming the rpn and lot number.Our laboratory evaluation of the product said to be involved confirmed the report.A visual examination of the device showed no damage to the catheter tubing or the balloon.A functional test was also performed on the returned device.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, balloon inflation was attempted.During the inflation attempt, the catheter was found to be blocked internally with dried contrast and the balloon would not inflate.The balloon was then cut off at the distal end in order to test the integrity of the balloon.During inflation of the balloon, water was noted to be leaking from the proximal area of the balloon, possibly from the catheter/balloon joint.A meeting was held with production management on 05/10/2023.During the meeting, a closer examination of the device revealed that the stream of water was leaking from a pinhole in the proximal end of the balloon material and not the catheter/balloon joint.No other anomalies were detected with the device.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 material was found to be leaking from a pinhole.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 report indicates that lubrication was not applied to the balloon prior to advancement down the accessory channel of the endoscope.The instructions for use direct the user to : "apply a water soluble lubricant to the balloon to allow easier passage through the accessory channel." the report also indicates that the device was used to dilate the duodenal papilla.The instructions for use state: "this device is used to dilate strictures of the biliary tree." the ifu also states: "do not use this device for any purpose other than the stated intended use." also, a possible contributing factor to a pinhole is if the balloon material comes in contact with a sharp object or burr in the endoscope accessory channel.Prior to distribution, all quantum ttc biliary balloon dilator are subjected to a leak test 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 unusual 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 lubrication was not applied to the balloon and device was used to dilate 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: 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: 16783970
• MDR Text Key: 314170813
• Report Number: 1037905-2023-00183
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002226569
• UDI-Public: (01)10827002226569(17)241006(10)W4522734
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/17/2023

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-8X3
• Device Lot Number: W4522734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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 - UNKNOWN MAKE AND MODEL
• Patient Age: 53 YR
• Patient Sex: Male