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Lot Number SSFC061223 |
Device Problem
Material Perforation (2205)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
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 atrial fibrillation (a fib) ablation procedure, a sureflex steerable guiding sheath was selected for use.During preparation, the medical engineer noted there was a crack on the sheath after unpacking it.The procedure was completed using another same of device.No patient complications occurred.The device is expected to be returned for analysis.No other issues were noted.
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Manufacturer Narrative
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The sureflex steerable sheath and dilator were returned for analysis.This supplemental mdr is being field.Analysis of the device during pre-decontamination visual inspection and testing confirmed the rotating knob worked properly for both sides, flushing was successful and no visible damages on tips or valves.Upon post-decontamination visual inspection and testing it was confirmed there were no damage, cracks, no issues found with rotation of the steering mechanism, and the sureflex cap handle and hub cap both remained attached to their respective bodies.The device passed the curve overlay test.Thus, the reported allegation was not confirmed.Additionally, the field g4 (premarket / 510(k) #) was updated.
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Event Description
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It was reported that during an atrial fibrillation (a fib) ablation procedure, a sureflex steerable guiding sheath was selected for use.During preparation, the medical engineer noted there was a crack on the sheath after unpacking it.The procedure was completed using another same of device.No patient complications occurred.The device is expected to be returned for analysis.No other issues were noted.
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Search Alerts/Recalls
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