BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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Lot Number VMFB290523 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and 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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Event Description
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It was reported that during the preparation of an left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.When the physician was attempting to connect, the dilator hub broke off.Hence to resolve the issue, a new kit was opened and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
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Search Alerts/Recalls
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