ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F; INTRODUCER, CATHETER
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Model Number 405104 |
Device Problem
Fracture (1260)
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Patient Problems
No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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During the procedure, the sheath did not peel properly and a scalpel had to be used to peel the device.When peeling, the sheath split into several pieces and had to be removed from the patient.There were no consequences to the patient.
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Search Alerts/Recalls
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