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

Catalog Number FS-QEB-XL-A

Device Problem Material Rupture (1546)

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

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

Common name and product code: gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.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 without the syringe.The balloon was ruptured and examined under magnification.Under magnification the balloon was examined and there was a portion where the balloon material did not match up and a portion appears to be missing.The missing portion of the balloon was not returned with the device.The device history record does contain a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Our evaluation of the returned device confirmed the report, the balloon material ruptured.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.In the information provided in the report, it states the balloon was tested prior to advancement down the endoscope accessory channel and inflated properly.A pinhole, split, or rupture in the balloon can occur if the balloon material has come into contact with a sharp object, such as a sharp stone or possibly a burr in the endoscope channel.A split or rupture in the balloon material can also occur if added pressure was applied during extraction.The instructions for use direct the user to "gently withdraw the inflated balloon toward the papilla." the instructions for use contain the following: ¿warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy.¿ 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.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.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook fusion quattro extraction balloon.It was reported [that the] user advanced the balloon device through wire guide and olympus endoscopy to bile duct, user then inflated the balloon with the syringe from package while found out the balloon cannot be inflated as expected.User retracted the device from patient and changed to another same device to complete the procedure.There was no reportable information at this time.The device was evaluated on 10/11/2022.It was determined that there was balloon material missing [subject of this report].It was reported that a section of the device did not remain inside the patient¿s body; however the location of the missing portion is unknown.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
• 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: 15717308
• MDR Text Key: 306902729
• Report Number: 1037905-2022-00607
• Device Sequence Number: 1
• Product Code: GCA
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: FS-QEB-XL-A
• Device Lot Number: W4542235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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 - OLYMPUS JF-260V
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 58 KG