MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-XL-A

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: olympus ercp catheter 0.025, visiglide 0.025 angle, clevercut.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The balloon was returned with the syringe still attached to the inflation port.The balloon was ruptured and appeared to be falling apart.During a lab meeting it was determined that the balloon material seems to have come in contact with a substance which may have caused additional damage, due to the degraded condition of the latex.We cannot determine if all the balloon material is present.It appears that there are portions of the balloon missing.A function test was not performed due to the condition the device returned in.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 a endoscopic retrograde cholangiopancreatography (ercp) for a stone removal performed in common bile duct (cbd), the physician used a cook fusion quattro extraction balloon.Physician performed balloon sweeping several times.However, he recognized that the balloon popped.So he removed [the balloon] and used an ebl-15-200.After that he inserted an enbd [cook nasal biliary drainage set] catheter and the case was finished.On 26-february-2020, the device returned.Our evaluation of the returned device determined a portion of the balloon is missing and was not included in the return of the device.This information was communicated to the user facility and the location of the missing section is unknown.The initial reporter stated that a section of the device did not remain inside the patient¿s body; however the location of the missing section detected during our laboratory evaluation 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
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• 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: 9855568
• MDR Text Key: 221915314
• Report Number: 1037905-2020-00146
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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