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

Catalog Number FS-QEB-XL-B

Device Problems Material Rupture (1546); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2014

Event Type  malfunction  

Manufacturer Narrative

Investigation eval: our eval of the returned device confirmed the report.A visual examination determined that balloon material is missing.The bulk of the balloon between the end section attached to the catheter was not returned.The end section of the balloon remain attached to the catheter.The balloon could not be inflated or hold pressure in this condition.There are frayed threads on the distal end of the balloon.The section of the balloon remaining attached to the catheter was tested with a ring gage and passed without difficulty.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 record 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 a 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 info provided indicated the balloon inflated properly prior to use.Therefore the balloon was intact and functioning prior to advancement through the endoscope.A split or rupture in the balloon material can occur if the balloon has come into contact with a sharp object such as a sharp stone, or possibly a burn in the endoscope channel.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 in the following warning: "do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy." prior to distribution, all fusion quattro 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: corrective action is not warranted at this time based on the quality engineering risk assessment.Qa will continue to monitor to complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic stone removal, a cook fusion quattro extraction balloon was used.After canulation of the papilla, the balloon was inserted into the common bile duct.The balloon ruptured during inflation.No section of the device detached inside the pt.The physician removed the device and used another device to complete the procedure.Our eval of the product said to be involved confirmed a section of the balloon material is missing and was not included in the return.Info regarding the missing section was communicated back to the medical facility.The location of the missing section is unk.The initial reporter stated that a section of the device did not remain inside the pt's body; however, the location of the missing section detected during our lab eval is unk.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.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• 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: 3869440
• MDR Text Key: 52388495
• Report Number: 1037905-2014-00147
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FS-QEB-XL-B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2014
• 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