Fsca number: 3005334138-11/22/21-001-r.The investigation showed that the returned dilator did not reach the distal end of the sheath while engaged.Further investigation revealed the sheath length did not meet manufacturing specifications, as a 12cm fast-cath hemo was processed and packaged in place of a 5cm ultimum hemo.Length measurements confirmed there was a component mix, which has been determined to be manufacturing related.
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During device preparation, when the sheath was flushed and the dilator was inserted into the sheath, it was noted that the sheath was longer than the dilator.The introducer was replaced, and the same issue was noted.Another introducer of a different lot was used to complete the procedure successfully with no adverse patient consequences.All boxes of lot number 7748246 to be returned (38 units).The used devices were discarded.
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