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

Catalog Number FS-QEB-A

Device Problems Burst Container or Vessel (1074); Material Separation (1562)

Patient Problems Inflammation (1932); Pain (1994); Jaundice (2187)

Event Date 01/15/2015

Event Type  Injury  

Event Description

During an endoscopic retrograde cholangiopancreatography procedure (ecrp) on (b)(6) 2015, a cook fusion quattro extraction balloon was used.While the physician was performing the sweep, the physician felt significant resistance pulling the balloon through the sphincterotomy site.The physician had to torque the endoscope, use the wheels and pull the catheter.The balloon popped.An in situ balloon test in front of the endoscope was performed and revealed the balloon had ruptured.They switched to a second balloon to successfully pull the stone out.The second balloon ruptured as well.A cholangiogram showed the duct was clear, although the stone was never seen in the duodenum.A sphincteroplasty was performed to extend the sphincterotomy.The physician placed a plastic stent in the duct and the case was finished.On (b)(6) 2015 the pt returned to the er for pain and elevated bilirubin.A ct scan was performed and showed a 5 mm defect.At this time the physician was unsure what remained inside the bile duct.Upon performing a sweep of the bile duct to remove the object, a section of the balloon used on (b)(6) 2015 popped out.

Manufacturer Narrative

As of (b)(6) 2015, the pt was much improved.The pt was treated for acute pancreatitis.A product eval was not performed in response to this report because the product said to be involved was not provided to cook for eval.Based on the photo provided by the user, we can confirm a section of possible balloon material was present inside the pt; however, we cannot determine a cause based on the photo.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.We could not conduct a complete investigation because the product said to be involved was not returned for eval.The info provided indicated that the balloon inflated properly prior to use; therefore, the balloon was intact and functioning prior to advancement through the endoscope.Balloon material damage can occur if the balloon has come into contact with a sharp object, such as a sharp stone or possibly a burr in the endoscope channel.Balloon damage could lead to subsequent balloon separation.Damage to the balloon material can also occur if added pressure was applied during extraction.The instructions for use direct the user to gently withdraw the inflated balloon toward the papilla.Potential complications associated with ercp include but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Assessment of the size of the stone and ampullary orifice must be made to determine the necessity of sphincterotomy.In the event sphincterotomy is required, all necessary precautions must be followed.Do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy.Infection of contrast during ercp must be monitored fluoroscopically.Overfilling of the pancreatic duct may cause pancreatitis.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 mfg requirements prior to shipment.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
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr, reg comm ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4531872
• MDR Text Key: 5359591
• Report Number: 1037905-2015-00049
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2015
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W3513190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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
• Treatment: OLYMPUS GIF 180 ENDOSCOPE
• Patient Outcome(s): Required Intervention