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

Catalog Number FS-QEB-A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the stylet wire in the purple wire guide port.The prepackaged syringe was not included with the returned device.A lab stock syringe was attached to the inflation port and the balloon was found to have a pinhole.The device measured at 202.3 cm from the distal end of the y-juncture hub which meets the specified requirement.The bends in the device start at approximately 190 cm from the distal end of the y-juncture hub.The distal end of the device exhibits significant bends.The ide port was observed under magnification and the ide port has been damaged.The proximal end of the ide port appears to be pressed inward as if it were smashed.This could have potentially been from the elevator on the side viewing endoscope.The distal end of the ide port is pointing outward creating a shape edge.The distance from the distal end of the ide port to the distal end of the tip of the device is 8.7 cm which is within tolerance.An additional functional verification was performed using the device to simulate an exchange using the intraductal exchange (ide) port.The balloon was advanced through a duodenoscope that was placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160v).Using a 0.035" tracer metro, a wire guide exchange was simulated.During the exchange, the wire guide remained in the simulated biliary duct and access was maintained.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 conclusion: 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 catheter exhibited damage (twisted, elongation and kinking of the ide port).The damage suggests excessive force was applied to the catheter.The damage to the ide port could contribute to difficulties during an exchange.The instructions for use state: "unlock short wire from wire guide locking device and advance tip of balloon catheter onto pre-positioned wire guide ensuring wire guide exits catheter at ide port." the instructions for use state: "advance device in short increments until it is endoscopically visualized exiting endoscope." this activity will aid in device preservation.If the elevator of the endoscope is placed in the closed position with the extraction balloon catheter inside the accessory channel, this can contribute to damage to the catheter.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), the physician chose a fusion quattro extraction balloon.The balloon had a slow leak.The device was received for evaluation on 11/30/17 and was found to have damage to the intraductal exchange (ide) port.

• 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: 7122667
• MDR Text Key: 95935471
• Report Number: 1037905-2017-00756
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002482258
• UDI-Public: (01)00827002482258(17)180718(10)W3890024
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: 11/08/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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