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

Catalog Number FS-CEB-A

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), a cook fusion quattro extraction balloon was used.The balloon would not deflate.The additional information provided stated the physician pulled the balloon up against the endoscope to get it to deflate.A section of the device did not remain inside the patient's body.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.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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 direct the user to inflate the balloon prior to use.By following the instructions for use, the user can determine 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 asset 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 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.

• 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: 4390289
• MDR Text Key: 5362428
• Report Number: 1037905-2014-00510
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2015
• Device Catalogue Number: FS-CEB-A
• Device Lot Number: W3464035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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 ENDOSCOPE (UNK MODEL NUMBER)