MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. FUSION QUATTRO EXTRACTION BALLOON

Catalog Number FS-QEB-A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the cook tracer hybrid wire guide was prepositioned in the bile duct.The fusion quattro extraction balloon catheter was advanced over the wire guide through the endoscope.As the balloon exited the distal end of the endoscope, the balloon sheared off the hydrophilic coating of the wire guide.See mdr 1037905-2015-00280.No section of the device detached inside the endoscope or patient.Another device was used to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual examination found the intra ductal exchange (ide) port was damaged.The stylet could be removed and reinserted.The distal end of the ide port is stretched out approximately 1 mm.There is some damage to the adhesive at the balloon joint the overall device length measured within the specification.A dimensional analysis of the ide port confirmed damage.The ide port dimensions were 6.7 mm located approximately 8.7 cm from the distal end.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 (model number olympus t jf-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.The catheter exhibited damage (stretched and flattened near the user end, 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 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 and this represents an unusual occurrence.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 nsk assessment results as post market feedback continues to become available.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4939663
• MDR Text Key: 6040788
• Report Number: 1037905-2015-00300
• Device Sequence Number: 1
• Product Code: GCA
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2016
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W3580366
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2015
• Event Location: Hospital
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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
• Treatment: OLYMPUS TJF-Q180V ENDOSCOPE; COOK TRACER HYBRID WIRE GUIDE (HYB-48015)