Model Number 405112 |
Device Problems
Difficult to Insert (1316); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant devices: peel-away introducer kit, 8f x2.
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Event Description
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Related manufacturing ref: 3005334138-2021-00504, 3005334138-2021-00506.During a pacemaker implant procedure, two dilators would not fit into the sheaths which caused a delay in the procedure.A third device was obtained and tested outside the patient and the same issue occurred.A fourth device was used to complete the procedure with no adverse consequences to the patient.
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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 loose or intermittent connection remains unknown.
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Event Description
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During a pacemaker implant procedure, two dilators would not click or stay on the sheath which caused a delay in the procedure.A third device was obtained and tested outside the patient and the same issue occurred.A fourth device was used to complete the procedure with no adverse consequences to the patient.
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Search Alerts/Recalls
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