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Model Number ICRC055137 |
Device Problems
Material Separation (1562); Stretched (1601)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
Injury
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Event Description
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During a stroke case, the treating physician used a zoom 88, zoom 55, zoom 35, and third party stent retriever.It was reported that after performing six passes, the distal segment of the zoom 55 was stretched and separated from the rest of the catheter but held together by the coil.The physician retrieved the entire zoom 55 catheter, including the separated portion.The patient was reported to be stable, and no patient sequelae were reported.Several attempts were made to have the treating physician provide further details of this event; however, they were unsuccessful.
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Manufacturer Narrative
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The device was discarded after use and therefore not available for return and investigation.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.The exact root cause of the separation could not be determined as the device was not returned for investigation, and there was limited information and no case images provided.Based on the information provided, the physician performed six passes with the same zoom 55.Instruction for use states, "do not perform more than 3 clot retrieval attempts with the zoom catheter.".
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Event Description
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Refer to h11 for follow-up information.
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Manufacturer Narrative
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Additional information was provided by the treating physician on 01/29/2024: the occlusion was in the distal left m1 segment.In the first pass, access was obtained with a zoom 88 access catheter and a zoom 55 aspiration catheter.The patient reportedly had a type 3 arch.The physician required some effort to navigate zoom 88 to the left internal carotid artery (ica) cavernous successfully.A slight bend was observed on the zoom 88 and the tip of the catheter was suspected to be ovalized.Suction was applied to the zoom 55 as it advanced forward.While retracting the zoom 55, the physician reported minimal resistance from the middle cerebral artery to the lateral; however, there was significant resistance halfway upon removal.The zoom 55 was removed from the patient.The physician found that the distal portion of the zoom 55 was stretched and still attached to the proximal part by two to three loops of coil.For passes two through six, the zoom 88 was kept in place in the left ica cavernous.The zoom 55 was replaced with a third-party aspiration catheter and a stent retriever.Since the balloon angioplasty did not work because it was a "white clot", the stent retriever was replaced by a different stent retriever.The case was completed with a successful removal of the clot.The patient was reported to be doing well with good improvement and the patient achieved complete reperfusion with a tici 3 score.
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Search Alerts/Recalls
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