WILSON-COOK MEDICAL INC TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING; GCA, CATHETER, BILIARY, SURGICAL
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Catalog Number TXR-8.5-12-15-A |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The balloon inflated and deflated without difficulty.The device was returned with the syringe still attached to the inflation port.A functional test was performed on the balloon; when the balloon was filled with air, no leaks were present in the balloon material.Once the balloon was inflated, pressure was released from the syringe and the balloon deflated within a few seconds (reference attached inflation/deflation video).The device was visually inspected and appeared to be free of bends and kinks along the catheter of the device.The device was measured from the hub to the distal end and measured in the specified tolerance.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 conclusion: our laboratory evaluation of the device could not confirm the complaint, the balloon inflated and deflated without difficulty.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 information provided indicates the balloon was inflated prior to use and inflated properly.This means the balloon was intact and functioning prior to advancement through the endoscope accessory channel.Prior to distribution, all tri-ex extraction balloons with multiple sizing 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.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 isolated occurrence.The likelihood of occurrence is considered remote.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.
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Event Description
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During an endoscopic retrograde cholangiopancreatography, the physician used a cook tri-ex extraction balloon with multiple sizing.It was reported [that] the balloon would not deflate as it should.The procedure was completed with this device, however it had to be manually deflated.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.
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Search Alerts/Recalls
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