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

Catalog Number FS-8.5-12-15-A

Device Problems Hole In Material (1293); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure, the physician used a cook fusion extraction balloon with multiple sizing.During patient contact, one balloon cannot be inflated while introduced into the endoscope.The procedure was completed by change a new balloon.The device was received for evaluation on (b)(6) 2015.Upon receipt of the device, it was noted that the intraductal exchange port was damaged.

Manufacturer Narrative

On 9/8/2015, we became aware that the information provided in the other remarks section was not submitted on the initial emdr.Investigation evaluation: our evaluation of the returned extraction balloon confirmed the report.The deflated balloon was submerged in water and a syringe and stopcock were attached to the inflation lumen.The balloon was inflated with air.Air bubbles were observed exiting the balloon material near the distal end of the balloon.The air exited the balloon due to a pinhole in the balloon material.No portion of the balloon material is missing.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.A visual examination found the intraductal exchange (ide) port was damaged.The stylet could be removed and reinserted.The distal end of the ide port is stretched out approximately less than 1mm.The overall device length measured approximately 202.4 cm from the hub which is within the specification.A dimensional analysis of the ide port confirmed damage.The ide port was twisted.The ide port dimension was located approximately 5.6 cm from the distal end.It was noted that there was some damage proximal to the ide port.A functional verification was performed using the device to simulate an exchange via 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.Using a.035" tracer hybrid wire guide, 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 damage to the ide port was twisted and bent.Attempts to recreate the failure of the ide port being twisted and damaged, using different wire guide exchange techniques were unsuccessful.Excessive force beyond normal use would be required to cause this type of damage to the device.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 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 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.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 extraction balloon with multiple sizing 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 EXTRACTION BALLOON WITH MULTIPLE SIZING
• 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: 5003282
• MDR Text Key: 23135712
• Report Number: 1037905-2015-00352
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-8.5-12-15-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 64