Model Number 87122 |
Device Problems
Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported that during an ablation procedure that during an ablation procedure using a blazer prime htd the tip of the catheter fractured.During first use of the catheter the device fractured towards the tip of the device and sharp metal was exposed.They exchanged the catheter and the issue was resolved.The procedure was then completed with no patient complications.The catheters is expected to be returned for analysis.
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Event Description
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It was reported that during an ablation procedure using a blazer prime htd the tip of the catheter fractured.The first time the catheter was torqued the device fractured towards the tip of the device and sharp metal was exposed.The catheter was removed with no additional interventions.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheters is expected to be returned for analysis.
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Manufacturer Narrative
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The device has not been received for analysis.However, a photograph of the damaged catheter was provided, and analysis was performed based on that picture.Visual inspect of the image showed kinking in the distal portion of the catheter shaft.The extent of the kink or fracturing could not be determined.With all the available information boston scientific confirms the allegation of fracturing in this complaint.The most likely cause is adverse event related to the procedure, as it is likely that factors encountered during the procedure and/or the manner in which the device was handled could have caused the kink in the catheter.
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Search Alerts/Recalls
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