BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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Lot Number VMFE050523 |
Device Problems
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 06/30/2023 |
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 a watchman procedure for left atrial appendage closure (laac), a versacross connect kit was selected for use.The physician inserted the mechanical j-wire into the superior vena cava (svc).The wire slipped bac in to the right atrium while loading the versacross connect and watchman sheath up to the svc.When the guidewire was pulled back and attempted to anchor it into the svc, it got stuck on the dilator tip and would not advance after an inch out of the dilator tip.The physician then removed the dilator and guidewire out of the patient and no damages were noted on the dilator or guidewire.Another attempt was made to loading the back end of the guidewire through the dilator however it got stuck and was not able to go through the entire dilator.Hence to perform the transseptal puncture, the versacross radio frequency wire and boston scientific dilator was used.The procedure was completed successfully and no patient complications occurred.The guidewire was disposed, however the dilator will be returned.
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Search Alerts/Recalls
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