Model Number M00558780 |
Device Problems
Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a cre pro wireguided balloon was used during a esophageal dilatation procedure performed on (b)(6) 2021.During withdrawal/closure, the balloon was defective.The procedure was completed with the original device.No patient complications have been reported as a result of the event.
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a cre pro wireguided balloon was used during a esophageal dilatation procedure performed on (b)(6), 2021.During withdrawal/closure, the balloon was defective.The procedure was completed with the original device.No patient complications have been reported as a result of the event.
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Manufacturer Narrative
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Block h6: device code a04 captures the reportable event of balloon damaged/defective.Block h10: the returned cre wireguided balloon was analyzed, and a visual evaluation noted that the catheter was stretched and detached at approximately 78.9cm from the bifurcation.The balloon was cut and the remaining part didn't return.A microscopic evaluation of the balloon cut noted that a mechanical tool was used to perform the cut.No other problems with the device were noted.The reported event of balloon damaged/defective could not be confirmed because the balloon was cut and the remaining part was not returned for analysis.Additionally it was observed that the catheter was stretched and detached.It is possible that during deflation, the balloon was stuck within the scope and/or other support device during the procedure.Once this condition was present the user may have experienced resistance during the removal of the device which may have caused the user to apply extra force.The extra force may have caused the stretch on the catheter and as consequence detached it.It is possible that the user cut the balloon in order to separate the device from the scope.Based on the analysis performed and all the information gathered from the customer, the root cause of balloon damaged/defective cannot be established since the remaining portion of the balloon was not returned.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Search Alerts/Recalls
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