Model Number M0062101170 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
Event Type
malfunction
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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 medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a nephromax nephrostomy catheter balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, when the physician tried to inflate the balloon, the middle portion of the balloon would not fully inflate.It was also noticed that the catheter was kinked.The procedure was completed with another nephromax nephrostomy catheter balloon.The photos submitted by the customer confirmed the balloon irregular shape and catheter kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Event Description
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It was reported to boston scientific corporation that a nephromax nephrostomy catheter balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, when the physician tried to inflate the balloon, the middle portion of the balloon would not fully inflate.It was also noticed that the catheter was kinked.The procedure was completed with another nephromax nephrostomy catheter balloon.The photos submitted by the customer confirmed the balloon irregular shape and catheter kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Manufacturer Narrative
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Block h6: medical device problem code a0406 captures the reportable event of balloon irregular shape.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Block h6: medical device problem code a0406 captures the reportable event of balloon irregular shape.Block h10: investigation results: a visual examination of the returned complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Solidified media was present in balloon.No damage was found on the balloon material, tip, and shaft of the device.Both markerbands were undamaged and present on the shaft of the device.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
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Event Description
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It was reported to boston scientific corporation that a nephromax nephrostomy catheter balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, when the physician tried to inflate the balloon, the middle portion of the balloon would not fully inflate.It was also noticed that the catheter was kinked.The procedure was completed with another nephromax nephrostomy catheter balloon.The photos submitted by the customer confirmed the balloon irregular shape and catheter kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Search Alerts/Recalls
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