MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-A

Device Problems Deflation Problem (1149); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During the procedure, a cook fusion quattro extraction balloon was used.The balloon portion of the device would not deflate completely.The patient is unknown to provide additional information regarding the malfunction of this device.Our evaluation of the product said to be involved determined the balloon is missing from the catheter and not included in the return.Information regarding the missing section was communicated back to the medical facility.The location of the missing section is unknown.Our attempts to collect additional information regarding patient outcome were unsuccessful.The user facility provided the following: the patient is unknown, all available information is in the report.

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned product could not confirm the report.The device was returned with the balloon missing from the catheter.The balloon attachment points were still intact.There is some balloon material still present at both the distal and proximal attachment points.There are tears in the balloon material next to the attachment points.It appears that excessive force was applied to the balloon causing the balloon material to separate.Due to the condition of the balloon it is impossible to test it.The end of the catheter with the missing balloon was placed in a container of water.The syringe was pushed in and air could be seen exiting the skive.This indicates that there is an open skive as intended and the syringe is functioning.The skive was examined and was open as intended.In order to determine if the supplied syringe may have contributed to the report.The returned syringe was tested using a new fs-qeb-a balloon advanced into an olympus j130 endoscope using a simulated upper gl position, with the tip in a retroflexed position to simulate a worst case situation.The balloon would inflate as intended and when the syringe was released the balloon would deflate as intended.Therefore the syringe worked as intended.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 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.According to the information provided in the report it could not be determined if balloon integrity was verified prior to use by inflating the balloon.The instructions for use direct the user to inflated the balloon prior to use.Following the instructions for use it can be determined if balloon was functioning prior to advancement through the endoscope.To hold the balloon in an inflated state the stopcock is placed in the closed position.To deflate the balloon the instructions for use state, "once balloon is endoscopically visualized in the duodenum, turn stopcock to the open position and deflate balloon".A kink in the catheter can contribute to balloon deflation difficulty by blocking the inflation lumen.This can occur if the extraction balloon receives excessive pressure during product handling or advancement through the endoscope.The instructions for use direct the user to advance the deflated balloon in short increments through the accessory channel until it is visualized exiting the endoscope.This activity will aid in device preservation balloon material damage 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 or elevator.Balloon damage could lead to subsequent balloon separation.Damage to 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 and not to exert excessive pressure on the ampulla when extracting stones.The need for sphincterotomy needs to be addressed if the stone does not pass easily.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 actions: 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 wilt continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4001764
• MDR Text Key: 4707069
• Report Number: 1037905-2014-00287
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2014
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W3333045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2014
• Distributor Facility Aware Date: 10/22/2013
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2014
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2013
• 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: ENDOSCOPE (UNK MODEL NUMBER)