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Model Number M0062101420 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 nephromax balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.During unpacking, what seems to be a burn mark was noted on the catheter near the balloon.A photo submitted by the customer confirmed the foreign material present on the device.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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