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Model Number CAT8XTORQ115KIT-B |
Device Problems
Break (1069); Stretched (1601); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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The patient was undergoing a thrombectomy procedure in the subclavian vein using an indigo system aspiration catheter 8 (cat8) and a 12f non-penumbra short sheath.During the procedure, the physician completed multiple passes using the cat8 and sheath.While advancing the cat8 during another pass through one of the already implanted stents, the physician encountered resistance and the tip of the cat8 stretched and broke, but remained attached to the rest of the cat8.Therefore, the cat8 was removed.The procedure was completed using an indigo system aspiration catheter 12 (cat12) and the same sheath.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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