Model Number SSNF |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A procedure was performed using the safesept needle free (ssnf).When removing the wire into the dispenser, it was noticed that the distal "j" portion of the wire was missing.The device history was reviewed and found no anomalies.Proper materials and methods of manufacturing were utilized.Scanning electron microscopy (sem) was used to analyze the fractured wire and concluded that the failure appears to be due to an overstress event caused by a shear force that was too strong for the wire alloy.If additional information is provided in the future, a supplemental report will be issued.
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Event Description
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This was a double transseptal procedure.The wire crossed without any issues.The physician was unable to cross the septum with the sheath.The wire, dilator, and cannula were removed, leaving the sheath in the right atrium.When removing the wire into the dispenser, it was noticed that the distal "j" portion of the wire was missing.Imaging was used and found that the "j" portion of the wire remained in the patient.
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Manufacturer Narrative
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This follow-up report is to indicate why this submission was submitted past the 30-day mark.The information in this submission was submitted on 27jun2019.The acknowledgement letters were received and stated "delivered"; however, these letters were not downloaded to confirm successful delivery.The fda was contacted on 6sep2019 to understand why the submission was not on maude, and the process of reviewing the acknowledgement letters was explained.The original submission had a delivery failure due to excess characters in field d11.Therefore, the report was submitted again on 9sep2019 after the issue was corrected, and successful delivery was confirmed.
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Event Description
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This was a double transseptal procedure.The wire crossed without any issues.The physician was unable to cross the septum with the sheath.The wire, dilator, and cannula were removed, leaving the sheath in the right atrium.When removing the wire into the dispenser, it was noticed that the distal "j" portion of the wire was missing.Imaging was used and found that the "j" portion of the wire remained in the patient.
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Search Alerts/Recalls
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