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

Catalog Number FS-QEB-A

Device Problem Fracture (1260)

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

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual examination of the device was performed and the catheter was broken into two pieces with the stylet wire still in the device.The catheter was broken at 94 cm from the distal end of the y-juncture handle.There were several areas where the catheter was stretched and damaged due to possible excessive pressure being applied to the device.The catheter was broken in one of the stretched areas.The second piece of the catheter where the balloon is attached was measured at 130.5 cm.The intraductal exchange (ide) port was not damaged, but the distal end of the device was kinked and bent.A functional test of the balloon was not performed due to the condition of the returned device.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 conclusions: 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 instructions for use state: visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.The instructions for use state: using fluoroscopic visualization and keeping endoscope elevator open, gently withdraw the inflated balloon toward the papilla.Warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy.Kinks can occur if the product experiences excessive pressure during use and/or general handling.The instructions for use advise the user to advance the product through the accessory channel of the endoscope in short increments.This activity will aid in preservation of the product.Prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.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 and this represents an isolated occurrence.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 endoscopy procedure, the physician used a cook fusion quattro extraction balloon.The physician was sweeping the duct and at the distal end of the duct felt resistance.Force was used to remove the catheter.Upon removal, the catheter broke inside of the patient and [the catheter] was able to be removed along with the scope as it was partially inside of the scope upon breaking.The elevator on the endoscope locked the device in place as the physician removed it from the patient.Once the endoscope was removed from the patient, they unlocked the elevator on the scope and pulled the product out.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5360121
• MDR Text Key: 35687106
• Report Number: 1037905-2016-00005
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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: OLYMPUS ERCP ENDOSCOPE (UNKNOWN MODEL)