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Lot Number VXFM070223 |
Device Problems
Defective Device (2588); Device-Device Incompatibility (2919); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
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 a versacross access solution was selected for use during a cryo procedure.The mechanical guidewire got stuck inside the dilator and could not advance the wire.Thus, a new versacross kit was opened to be used.No patient complications were reported.The procedure was completed successfully.It was also noted that the mechanical guidewire was damaged/defective.The device is expected to be returned for analysis.
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Search Alerts/Recalls
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