Model Number 1871 |
Device Problems
Difficult to Insert (1316); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1.Initial reporter address 1: (b)(6).
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Event Description
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It was reported that a device separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the guidezilla was unable to fully insert inside sheath.Upon pulling out, plastic part of extension catheter separated from the wire.It was unknown if how the procedure was completed.There were no patient complications reported post procedure.
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Event Description
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It was reported that a device separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the guidezilla was unable to fully insert inside sheath.Upon pulling out, plastic part of extension catheter separated from the wire.It was unknown if how the procedure was completed.There were no patient complications reported post procedure.
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Manufacturer Narrative
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E1.Initial reporter address 1: (b)(6).The device was returned and evaluated by manufacturer: visual inspection revealed that the collar weld plate was separated and for a length of 8mm running proximal from the tip, the shaft and tip were flattened.Microscopic inspection revealed no further damage or irregularity.There was blood present in the shaft of the device.
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Search Alerts/Recalls
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