Lot Number VMFC140723 |
Device Problems
Defective Device (2588); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
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 connect access solution was selected for use during a left atrium appendage implant.It was noted that the mechanical guidewire has a coating issue.It looks like it was shredded.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.No other issues were noted.
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Event Description
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It was reported that a versacross connect access solution was selected for use during a left atrium appendage implant.It was noted that the mechanical guidewire has a coating issue.It looks like it was shredded.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.No other issues were noted.
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Manufacturer Narrative
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The device has not been received for analysis.This is supplemental mdr to report investigation results (mdr aware date 15feb2024).Analysis of the device found that the mgw (mechanical guidewire) has unraveled at the distal end as exemplified by the loose distal tip coil which did not show the j shape tip and the stretched out coil rendering the wire core visible.Additionally, it was noted that the guidewire's unravelling is caused at the distal j tip.There are no notable kinks along the guidewire proximal to the floppy distal tip.Wire outer diameter measurements were taken with passing results compared to the drawing specifications.From vhx imaging, it was noted a minor coil stacking is present at the distal tip of the mgw.Also, the unraveling caused by the core wire fracture occurs at a critical location in terms of stress resistance and the fracture site shoes sing of necking which points to a ductile failure.Therefore, there is no sign of irregularities nor material quality concern.The reported allegations are confirmed.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.
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Event Description
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It was reported that a versacross connect access solution was selected for use during a left atrium appendage implant.It was noted that the mechanical guidewire has a coating issue.It looks like it was shredded.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.No other issues were noted.
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Manufacturer Narrative
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**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.
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Search Alerts/Recalls
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