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

Catalog Number FS-QEB-A

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During our evaluation of the device, the balloon was inflated with air but appeared to have some liquid substance inside of the balloon, and the balloon would not inflate all the way.The balloon was submerged in water with no leaks or bubbles.When the balloon was attempted to be deflated, the balloon would not fully deflate.It is possible that the unknown substance is clogging the inflation lumen causing the balloon not to deflate.A visual inspection of the bands were verified and the bands were in the correct location.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 information provided indicated the balloon inflated properly prior to use.Therefore, the balloon was intact and functioning prior to advancement through the endoscope.If a substance other than air is used to inflate the balloon, such as contrast or saline, this can cause balloon deflation difficulties.Due to residual air in the inflation lumen, a mixture of air and liquid will enter the area inside the inflated balloon.The presence of air and liquid inside the inflated balloon will create resistance in balloon deflation.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 duodenum, turn stopcock to 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.This activity will aid in device preservation.Prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functionally tested 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon.As reported to customer relations: "they had a difficult time deflating the balloon.The physician did a sweep and did not need another balloon.".

• 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: 5938980
• MDR Text Key: 54294221
• Report Number: 1037905-2016-00345
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002482258
• UDI-Public: (01)00827002482258(17)170614(10)W3729549
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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 (UNKNOWN MODEL)