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Model Number H7493932430 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device evaluated by manufacturer: 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.(b)(4).
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Event Description
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It was reported that a guidewire fractured.During a percutaneous transluminal coronary angioplasty (ptca) procedure, a comet pressure guidewire was used to perform a fractional flow reserve evaluation in the right coronary artery.Then, the same wire was used to evaluate the binary stenosis in the left anterior descending artery (lad).The wire was advanced to the lad with no resistance.The physician decided to withdraw the wire a little bit because the tip was not in the main vessel but in a small branch.When he tried to withdraw the wire the tip didn't follow the proximal part of the wire.A trapping balloon technique was used to successfully remove the wire and the tip.The wire was broken in four different parts.Intravascular ultrasound (ivus) was used to confirm the wire removal was successful.The procedure was completed with a different device.There were no patient complications and the patient status is stable.
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Search Alerts/Recalls
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