MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-8.5-12 15-A

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

During an endoscopy procedure, the physician used a cook fusion extraction balloon with multiple sizing.The physician was using an extraction balloon which burst.On removing the extraction balloon, the tip of the balloon was broken off and left in the pt's common bile duct (cbd).The physician tried to remove the detached tip by using another balloon behind it, a basket and finally applying suction with a syringe.Unfortunately all were unsuccessful.The physician has spoken to the pt and explained this [event].The physician arranged an x-ray in a week or so to check to see if it has moved.An add'l device was returned with the original complaint device (medwatch report number 1037905-2015-00214).On 05/26/2015, the device was returned for eval.Our eval results determined balloon material is missing and was not included in the return.This type of occurrence has been established as a reportable event.Info regarding the missing section ws communicated back to the medical facility.

Manufacturer Narrative

The location of the missing section is unk.The description of event for the add'l device returned is unk at this time.It is unk if a section of the device remained inside the pt's body.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.Investigation eval: our eval of a returned device determined that a section of balloon material is missing.This was determined by a visual examination.The section of material was not returned.The balloon ends are intact and secured underneath the threads.The balloon material that is still intact does not match up.Due to the condition of the balloon, it cannot be inflated because balloon material is missing.A product specific discrepancy that could have caused or contributed to this observation was not observed during our lab analysis.A review of the device history could not be conducted because the lot number was not provided.Investigation conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the lab setting.Due to variety of clinical conditions such as pt anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our lab analysis.This limits our ability to conclusively determine a cause.The instructions for use states: the intended use for this device is endoscopic removal of stones in the biliary system and for contrast injection.A split or rupture in the balloon material can occur if the balloon was inflated in excess of the recommended inflation volume.The instructions for use direct the user to attach the enclosed syringe to the stopcock (which is attached to the inflation port) to inflate the balloon.A split or rupture in 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.The instructions for use contain the following warning: "do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy".A split or rupture in the balloon material can occur if the balloon has come into contact with a sharp object.Prior to distribution, all fusion biliary extraction balloons 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.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.Qa 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): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4875821
• MDR Text Key: 6063980
• Report Number: 1037905-2015-00261
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: ENDOSCOPE (UNK MODEL OR MODEL)