Model Number 7760 |
Device Problems
Fracture (1260); Difficult to Insert (1316); Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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Event Description
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It was reported that the device was fractured.A model-5f expo multipack 145 (5pkx3) was selected for percutaneous coronary intervention (pci).During the procedure, the expo catheter multipack found to have a stricture in the 'l' catheter of multiple catheters in the pack which made them difficult to flush and impossible to pass a wire.Furthermore, it was noted that the device was fractured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
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Manufacturer Narrative
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H6: device codes: corrected from difficult to insert a150206 to difficult to advance a150205.
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Event Description
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It was reported that the device was fractured.A model-5f expo multipack 145 (5pkx3) was selected for percutaneous coronary intervention (pci).During the procedure, the expo catheter multipack found to have a stricture in the 'l' catheter of multiple catheters in the pack which made them difficult to flush and impossible to pass a wire.Furthermore, it was noted that the device was fractured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
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Search Alerts/Recalls
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