MAUDE Adverse Event Report: COOK ENDOSCOPY 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 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Common name: gca biliary catheter for stone removal that may also allow for irrigation and contrast injection investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the syringe still attached to the inflation port.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 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 user stated the balloon integrity was not verified prior to use.The instructions for use includes the following under system preparation "verify balloon integrity prior to use by attaching the enclosed syringe to the stopcock and inflating the balloon with air only.If any leakage is detected, do not use." 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 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.Additional comments regarding this report: based on the information provided that the user didn't verify the balloon integrity prior to use, 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 a endoscopic retrograde cholangiopancreatography (ercp) for a stone removal performed in the common bile duct (cbd), the physician used a cook fusion quattro extraction balloon.It was initially reported that after inserting the reported balloon into the bile duct, the physician attempted to inflate the balloon at the first time, but he confirmed that it could not be inflated.Therefore, another of the same device was used instead.The procedure was completed without problems.There was no reportable information at this time.Per evaluation of device returned on 09/21/2021: the balloon was ruptured and under magnification not all portions of the balloon material matched up and a portion was missing.[subject of report] per further communication received on (b)(6) 2021: the representative talked with the dealer who contacted with a medical person attending the procedure.The user [physician] did not perform inflation check prior to use and noticed that the device could not be inflated at the first inflation.Medical people attending the procedure could confirm that the balloon was not inflated, but they were not aware of the fact that a portion of the balloon material of the device was missing.The representative said that judging from the situation and the fact that there was no report from the doctor that the portion of the balloon remained in the body, so it was assumed that the portion did not remain in the body.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
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12661902
• MDR Text Key: 284147790
• Report Number: 1037905-2021-00579
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002319216
• UDI-Public: (01)10827002319216(17)211001(10)W4390859
• 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
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: FS-QEB-XL-A
• Device Lot Number: W4390859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS JF260V ENDOSCOPE