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

Catalog Number FS-QEB-XL-B

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: 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 and the prepackaged syringe.A visual examination of the balloon material indicated that the balloon material had ruptured.The device measured 202.2 cm from the distal end of the y-juncture hub (handle of the device) which meets the specified requirement.The device exhibited a slight bend near the distal end of the device.A further evaluation of the device observed that the intraductal exchange (ide) port has been damaged.The distal end of the ide port has been pulled outward approximately 1 mm creating a sharp edge.The distance from the distal end of the ide port to the distal end of the tip of the device is 8.6 cm which is within tolerance.Due to the balloon material being ruptured, a functional test was not performed by advancing the device down a side viewing endoscope for concerns of the balloon material detaching from the device.A review of the device history record could not be conducted because the lot number was not provided.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 prepositioned wire guide, ensuring wire guide exits catheter at zip 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 cook fusion quattro extraction balloon to extract bile duct stone(s).Before the balloon was advanced into the endoscope, the user confirmed that the balloon inflated.At first collection of the stone, the balloon was inflated securely, so the stone was extracted.Then, at the second attempt, it was confirmed that the balloon would not inflate in the bile duct.[the user] removed [the balloon] from the patient and found the balloon was damaged, so it was replaced with another fusion quattro extraction balloon to extract rest of the stones.There have been no adverse effects to the patient reported.There was no reportable information at that time.The device was received for evaluation on 01/04/18 and was found to have damage to the intraductal exchange (ide) [zip] port.

Manufacturer Narrative

Corrected data: section h6 and section h10 - "additional mfg narrative-notes" - investigation conclusion investigation evaluation: 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 and the prepackaged syringe.A visual examination of the balloon material indicated that the balloon material had ruptured.The device measured 202.2 cm from the distal end of the y-juncture hub (handle of the device) which meets the specified requirement.The device exhibited a slight bend near the distal end of the device.A further evaluation of the device observed that the intraductal exchange (ide) port has been damaged.The distal end of the ide port has been pulled outward approximately 1 mm creating a sharp edge.The distance from the distal end of the ide port to the distal end of the tip of the device is 8.6 cm which is within tolerance.Due to the balloon material being ruptured, a functional test was not performed by advancing the device down a side viewing endoscope for concerns of the balloon material detaching from the device.A review of the device history record could not be conducted because the lot number was not provided.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 prepositioned wire guide, ensuring wire guide exits catheter at zip 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.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): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7225391
• MDR Text Key: 98787264
• Report Number: 1037905-2018-00029
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-XL-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE AND MODEL