MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON

Catalog Number FS-QEB-XL-A

Device Problem Material Rupture (1546)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device common name and product code: biliary catheter for stone removal that may also allow for irrigation and contrast injection - gca.Initial reporter; occupation: unknown.Investigation evaluation: the product said to be involved was returned in a yellow bio bag.The lot number which matches the report was written on the bio bag however no product pouch was provided.Our laboratory evaluation of the product said to be involved determined that portions of the balloon material were missing.The balloon was returned with the balloon ruptured and under magnification it was noted that portions of the balloon material are 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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The information provided indicated the balloon inflated properly prior to use.Therefore, the balloon was intact and functioning prior to advancement through the endoscope.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 (fs-qeb-xl-a).The user removed the stone with the basket during an ercp, then utilized the fs-qeb-xl-a to clean the rest of the stones, but the balloon burst while pulling the balloon towards the duodenal papilla.As the wire guide fell out of the duodenal papilla due to the balloon bursting, the user needed to make access into the duodenal papilla again and the procedure was completed with a domestic brand of a similar device.There was no reportable information at this time.On 14 jan 2021, the device returned.Our evaluation of the returned device determined that portions of the balloon material were missing [subject of report].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: 11300870
• MDR Text Key: 246296726
• Report Number: 1037905-2021-00046
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002319216
• UDI-Public: (01)10827002319216(17)210819(10)W4377142
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: FS-QEB-XL-A
• Device Lot Number: W4377142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 55