MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-XL-A

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/09/2024

Event Type  malfunction  

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 device was returned in a coiled position with the syringe still attached to the inflation port.The balloon was inflated with air using the syringe provided.The balloon inflated as expected and the stop cock was turned to closed.A visual examination of the balloon did not find any leaks or defects.Upon turning the stopcock to open, the balloon would not deflate.Under visual magnification it was noted that there was fluid within the balloon suggesting it was inflated with a liquid instead of air.The syringe had to be removed and the balloon manipulated in order for the balloon to fully deflate.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: our laboratory evaluation of the returned device confirmed the report.There was a liquid present inside the balloon which suggests the balloon was not inflated with air.The instructions for use (ifu) states: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating balloon with air only." this is the most likely cause for the balloon being unable to deflate.Prior to distribution, all fusion quattro extraction balloon 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 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 there was a liquid present inside the balloon which suggests the balloon was not inflated with air, 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.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook fusion quattro extraction balloon.The balloon would not deflate [subject of report] it was reported [that] the nurse had to remove the syringe to deflate the balloon.A second balloon was used to complete the procedure.With a new balloon, the procedure was done successfully.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.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• 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: 18640741
• MDR Text Key: 334552675
• Report Number: 1037905-2024-00065
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-XL-A
• Device Lot Number: W4765505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• 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: FS-OMNI-AWG2-35-260; OLYMPUS 190 DUODENOSCOPE
• Patient Sex: Female