MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION QUATTRO EXTRACTION BALLOON

Model Number G48226

Device Problem Deflation Problem (1149)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

Gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.The device was received at the time of report submission and the investigation is in progress.A follow up emdr will be sent.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook fusion quattro extraction balloon.It was reported that the physician wanted the balloon turn down to 8.5mm, but the nurse found that the balloon couldn't turn down deflate.The physician used force to pulled it out of the papilla.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 device was returned in an open pouch with the lot number provided in the report.The label matches the product returned.The video provided shows one device in use, the user was attempting to deflate the balloon.The user inflated the balloon with the syringe provided, turned the stopcock to deflate the balloon, but the balloon did not deflate.It was noted in the video that there was liquid in the balloon.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described, because the balloon inflated and deflated without difficulty.The device was returned with the syringe provided with the product.A functional test was performed on the balloon using the returned syringe.The syringe was attached to the inflation port.When the balloon was filled with air, no leaks were present in the balloon material.Once the balloon was inflated, pressure was released from the syringe and the balloon deflated within a few seconds.The device was visually inspected and appeared to be free of bends and kinks along the catheter of the device.The device was measured from the hub to the distal end and measured within the specified tolerance.The complaint is considered confirmed based solely on the video provided and statements describing the event.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 indicates the balloon was not inflated prior to use.The ifu states: "verify the balloon integrity prior to use by attaching the enclosed pre-measured syringe to the stopcock and inflating the balloon with air only." prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.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 isolated occurrence.The likelihood of occurrence is considered remote.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 the balloon was not inflated prior to use, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: FUSION QUATTRO EXTRACTION 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: 14565075
• MDR Text Key: 297250726
• Report Number: 1037905-2022-00263
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002482265
• UDI-Public: (01)00827002482265(17)230203(10)W4562047
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: G48226
• Device Catalogue Number: FS-QEB-B
• Device Lot Number: W4562047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG