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Model Number M0062101180 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
Injury
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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 balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon burst and the physician had to retrieve the fragments of the balloon.The procedure was completed with another nephromax balloon.The patient outcome was reported to be fully resolved.
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Search Alerts/Recalls
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