MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-XL-A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/07/2015

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon.The balloon snapped [ruptured] and customer reported that it is due to the connection between the balloon and the catheter.The customer believes a little black ring [biocompatible black ink flakes] detached inside the patient.Another device of the same type was used to complete the procedure.On 8/31/2015, the device returned to cook for evaluation.Our evaluation determined the ide port is damaged.Ide port damage is considered a reportable event.

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.Concomitant medical products: cook acrobat calibrated tip wire guide (acro-35-205).Investigation evaluation: a visual examination found the intra ductal exchange (ide) port was damaged.The stylet could be removed and reinserted.All of the radiopaque bands were present.The balloon material had a pinhole and was split.The distal end of the ide port is stretched out more than 1 mm.The overall device length was measured and is within the specified length.A dimensional analysis of the ide port confirmed elongation damage.The damaged ide port dimensions are 8.0 mm which is outside the specified tolerance.The ide port appears to be stretched severely toward the distal end of the device as well as the wall of the ide port.The ide port is located 8.6 cm from the distal end.A functional verification was performed using the device to simulate an exchange via the ide port.The duodenoscope has an accessory channel that is 4.2mm in diameter (model number olympus tjf-160v).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 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.A possible cause of the damage exhibited at the ide port suggests excessive force was applied which 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 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.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5059324
• MDR Text Key: 25113480
• Report Number: 1037905-2015-00383
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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