Model Number M0062101170 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a0414 captures the reportable event of torn material.
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Event Description
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It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithonomy (pcnl) procedure performed on august 31, 2023.During the procedure, the nephromax balloon was torn was soon as it was inflated.The procedure was completed with another nephromax nephrostomy balloon catheter.No patient complications have reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a0414 captures the reportable event of torn material.Block h2: additional information: block d4 (lot number) have been updated based on the additional information received on (b)(6) 2023.Block h10: investigation result a visual examination of the returned complaint device found that the balloon had a longitudinal tear beginning approximately 5mm proximal of the distal markerband and extending approximately 12mm proximal from the distal markerband.A visual and tactile examination revealed no issues or damage with the tip and the shaft.Additionally, there was no issues noted with the markerband.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.Based on the available information, there was no evidence of a manufacturing or design issue which could have caused the complaint and there is no evidence that the device failed to meet nephromax ng specification prior to shipping.Additional information was requested with regards to patient anatomy and lesion characteristics; however, this information was not available.It is possible that difficult patient anatomy contributed to the longitudinal tear in the balloon material.This device was used during a percutaneous nephrolithotripsy (pnl) procedure, which is a procedure to treat kidney stones of the nephrostomy tract.It is possible that the balloon had an interaction with a stone when the device was being positioned causing a weakness in the balloon material which ruptured and tore when positive pressure was applied to it.Therefore, the most probable root cause is adverse event related to procedure.
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Event Description
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It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, the nephromax balloon was torn as soon as it was inflated.The procedure was completed with another nephromax nephrostomy balloon catheter.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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