Catalog Number 9-TV45X45-14F-080 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2023, a 14f amplatzer torqvue 45x45 delivery sheath was chosen for procedure.During procedure, when the sheath was introduced to the patient over a 0.035 inch non-abbott guidewire, it was noted that the dilator had torn at the tip.The damaged sheath was introduced to the patient.A new 14f amplatzer torqvue 45x45 delivery sheath was used.There was delay in the procedure but no hemodynamic compromise or serious injury.There was no reported adverse patient effects.The patient was stable.
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Manufacturer Narrative
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An event of dilator tip torn while introducing the sheath into the patient was reported.It was reported that the torn tip was noted when the sheath was introduced to the patient over a 0.035 inch non-abbott guidewire.The device was returned to abbott for investigation and the tip of dilator was noted split.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Abbott is performing further investigation to monitor this issue.Coding removed : 2017 a2303 improper or incorrect procedure or method.
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Event Description
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It was reported that on (b)(6)2023, a 14f amplatzer torqvue 45x45 delivery sheath was chosen for procedure.During procedure, when the sheath was introduced to the patient over a 0.035 inch non-abbott guidewire, it was noted that the dilator had torn at the tip.The damage was noted while introducing the sheath into the patient at which point the sheath and dilator were removed from the wire.A new 14f amplatzer torqvue 45x45 delivery sheath was used.There was delay in the procedure but no hemodynamic compromise or serious injury.There was no reported adverse patient effects.The patient was stable.
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Search Alerts/Recalls
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