Model Number 7015 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that catheter entrapment on guidewire occurred.The target lesion was located in right coronary artery (rca).A guidewire and a 4.0mm x 15mm quantum maverick balloon catheter were advanced for use; however, during the procedure, the guidewire failed to advance.The guidewire was then removed but it was unable to detach from the balloon.The procedure was completed with another of the same device.There were no patient complications reported.
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that catheter entrapment on guidewire occurred.The target lesion was located in right coronary artery (rca).A guidewire and a 4.0mm x 15mm quantum maverick balloon catheter were advanced for use; however, during the procedure, the guidewire failed to advance.The guidewire was then removed but it was unable to detach from the balloon.The procedure was completed with another of the same device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon was tightly folded.The device had a shaft kink at the proximal end of the distal markerband.The tip of the device was damage.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire failed to pass through the device due to the shaft kink within the balloon.Resistance was met when the guidewire was fed through the rapid port exchange (exit notch) and through the tip once it met the shaft kink.No other irregularities were found during wire testing.E1-initial reporter facility name: (b)(6).
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Search Alerts/Recalls
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