BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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Device Problems
Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Event Description
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It has been reported that a versacross steerable access solution kit has been selected for use for a watchman procedure indicated to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire became stuck as it was being withdrawn from the dilator.The physician removed both the dilator and guidewire together from the patient and completed the procedure successfully using a new versacross kit (different device, different model).No patient complications reported.Product is expected to return for analysis.
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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 has been reported that a versacross connect access solution has been selected for use for watchman procedure indicated to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire became stuck as it was being withdrawn from the dilator.The physician removed both the dilator and guidewire together from the patient and completed the procedure successfully using a new versacross kit (different device, different model).No patient complications reported.Product is expected to return for analysis.It was further reported that the mechanical guidewire was exposed to the patient when it got stuck and also became kinked.No visible or anatomical issues were present.The dilator was slightly reshaped prior to use, as per usual.
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Manufacturer Narrative
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Due to additional information, the fields b5 (describe event or problem), d1 (brand name), d2a (common device name), d2b (pro code (product code)), f10, h6 (device codes) and g4 (premarket / 510(k) #) were updated, thus the supplemental medwatch is being field.The device has not been received for analysis yet.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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Manufacturer Narrative
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The versacross dilator and mechanical guidewire (mgw) have been received for analysis, thus this supplemental mdr is being filed to report investigation results.Upon receipt at boston scientific's post market laboratory, both devices were visually inspected.The dilator had gross curvature, but likely due to shipping conditions rather than events of complaint; and the mgw was kinked at its distal end, it has overlapping (stacking) coils proximal to j-tip and distal to kink.Therefore, the reported allegation was confirmed.
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Event Description
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It has been reported that a versacross connect access solution has been selected for use for watchman procedure indicated to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire became stuck as it was being withdrawn from the dilator.The physician removed both the dilator and guidewire together from the patient and completed the procedure successfully using a new versacross kit (different device, different model).No patient complications reported.Product is expected to return for analysis.It was further reported that the mechanical guidewire was exposed to the patient when it got stuck and also became kinked.No visible or anatomical issues were present.The dilator was slightly reshaped prior to use, as per usual.
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