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Model Number LVZRMS180J |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during the implant procedure, while extracting the guidewire from the left ventricular (lv) lead, the physician felt abnormal resistance, which was not felt during lead placement over the guidewire.After the total retraction of the guidewire, it was observed the guidewire was frayed and damaged and with a "different aspect" when compared to the beginning.The guidewire and lv lead were replaced due to the physician's concern that the lv lead may have had particles in the lead lumen.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the partial guidewire was returned and analyzed, guidewire was broken.The stylet/guidewire was kinked/buckled.The guidewire was unraveled.Visual analysis of the lead indicated damage during use.The analyst noted that approximately 3cm of the distal end of guidewire was broken off and not returned.The guidewire could not be used for insertion test in returned lead.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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