MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON

Model Number G31921

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: common name and product code: gca biliary catheter for stone removal that may also allow for irrigation and contrast injection, gca investigation evaluation: our laboratory evaluation of the product said to be involved determined that pieces of the balloon material are missing.The balloon was returned with the syringe still attached to the inflation port.The balloon was ruptured and socked over the distal tip.The balloon was rolled back in position and examined under magnification.There are sections of the balloon that do not match up.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: 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.A split or rupture in the balloon material can occur if the balloon 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 balloons 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 (ercp) procedure, the physician used a cook fusion quattro extraction balloon.A stone was taken out with the first use of the device, but when they attempted to take out the rest of the stones, they found out the balloon was broken.The procedure was completed with another cook fusion quattro extraction balloon.This event was not reportable at that time.On 12-nov-2019, the device returned.The sections of the balloon do not match up [pieces of the balloon material are missing].It was reported that a section of the device did not remain inside the patient¿s body; however the location of the missing portions 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): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 9432763
• MDR Text Key: 218710333
• Report Number: 1037905-2019-00746
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002319219
• UDI-Public: (01)00827002319219(17)200618(10)W4227556
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Model Number: G31921
• Device Catalogue Number: FS-QEB-XL-A
• Device Lot Number: W4227556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 55