Model Number 87047 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: (b)(6) years, or older.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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During an ablation procedure to treat atrial fibrillation and atrial flutter a intellanav mifi open-irrigated (oi) catheter was selected for it.It was reported that the irrigation port of the catheter was broken.The catheter was replaced with another intellanav mifi oi catheter, and the procedure was completed successfully without patient complications.
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Manufacturer Narrative
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Age at time of event: 18 years or older.The device was returned to boston scientific for analysis.Visual inspection noted that the adhesive and irrigation tubing were torn open at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.
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Event Description
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During an ablation procedure to treat atrial fibrillation and atrial flutter a intellanav mifi open-irrigated (oi) catheter was selected for it.It was reported that the irrigation port of the catheter was broken.The catheter was replaced with another intellanav mifi oi catheter and the procedure was completed successfully without patient complications.
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Search Alerts/Recalls
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