Catalog Number 54038KA2 |
Device Problems
Break (1069); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during an arteriogram procedure, the catheter tip partially detached within the patient.The physician had successfully acquired retrograde arterial access.Under fluoroscopy it was noted that contrast was coming out of the shaft where the rubber tip is fused.The partially detached catheter tip was successfully removed together with the guidewire.No patient injury to report.
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Manufacturer Narrative
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The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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