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Model Number 401771 |
Device Problem
Material Separation (1562)
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Patient Problem
Heart Block (4444)
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Event Date 12/11/2021 |
Event Type
Injury
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Event Description
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During a procedure conducted to treat a third degree atrioventricular block that the patient had prior to the procedure, due to a malfunction with the pacing catheter and not being able to use the device, the patient had to be given an intravenous drip of isoproterenol.Initially a pacing catheter was wanted to be used for intracardiac pacing to help increase the patient's heart rate.During application, it was found that the connection between the red negative electrode and the pacemaker was separated.Moreover, the outer coating of the wire detached from the internal wire and red electrode.The patient was immediately given an intravenous drip of isoproterenol, and the temporary pacemaker electrode was replaced for heart rate elevation.There were no adverse consequences to the patient due to the fracture of the connection between the red negative electrode and the pacemaker.The patient's third degree atrioventricular block was able to be treated and the patient was noted to be stable.
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Manufacturer Narrative
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Additional information: g3, h2, h3, h6.Two images were submitted for evaluation to product performance engineering; no device components were returned.The photos appeared to show a 6f pacel bipolar pacing catheter.The braid wire appeared to have fractured near the bifurcation area, resulting in wire exposure and separation of the leg wire tubing from the connector pin assembly.Visual inspection was based solely upon a review of the photographs provided.The device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported wire detachment could not be determined.
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Search Alerts/Recalls
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