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

Catalog Number FS-QEB-XL-A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: boston scientific jagwire wire guide.Investigation evaluation: our laboratory evaluation of the product said to be involved determined there was damage at the ide port.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 laboratory stock syringe was attached to the inflation port and the balloon inflated and deflated as intended.The device measured at 202.7 cm from the distal end of the y-juncture hub which meets the specification.The bends in the device start at approximately at 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 side walls of the ide port are damaged.The distance between the distal end of the ide 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 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 hybrid, 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 states: "unlock short wire from wire guide locking device and advance tip of balloon catheter onto prepositioned wire guide ensuring wire guide exits catheter at ide port." the instructions for use states: "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 used a cook fusion quattro extraction balloon.All the information i have is on a note that is stuck to the package which says, "split at end by another manufacturer's wire guide." the customer does not recall how or when this occurred.I do not know when this occurred.The device was evaluated on 11/17/2017 and it was observed that the intraductal exchange (ide) port was damaged and protruding.

• 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: 7108435
• MDR Text Key: 95768844
• Report Number: 1037905-2017-00749
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002319219
• UDI-Public: (01)00827002319219(17)180411(10)W3848750
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-XL-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: 11/17/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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