BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24691 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/18/2019 |
Event Type
Injury
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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 the balloon became stuck and the distal tip detached when removed.Vascular access was obtained via ipsilateral antegrade approached.The 99% stenosed target lesion was in a severely tortuous and severely calcified right plantar artery.A 1.5mmx20mmx143cm coyote balloon catheter and a 6f guidezilla ii pv long guide extension catheter were used for treatment.During procedure, the balloon was unable to pass through the guidezilla ii and inflation was performed once at that position.When the balloon was tried to remove after inflation, it was noted to be stuck and the distal tip of the balloon became separated/detached.The detached balloon was retrieved using another method.No further patient complications were 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 the balloon became stuck and the distal tip detached when removed.Vascular access was obtained via ipsilateral antegrade approached.The 99% stenosed target lesion was in a severely tortuous and severely calcified right plantar artery.A 1.5mmx20mmx143cm coyote balloon catheter and a 6f guidezilla ii pv long guide extension catheter were used for treatment.During procedure, the balloon was unable to pass through the guidezilla ii and inflation was performed once at that position.When the balloon was tried to remove after inflation, it was noted to be stuck and the distal tip of the balloon became separated/detached.The detached balloon was retrieved using another method.No further patient complications were reported.It was further reported that the occluded target lesion was in the anterior tibial artery.The balloon was inserted from dorsal plantar artery and plantar artery to the posterior tibial artery with the guide extension catheter.However, the balloon could not go any farther that the middle of the plantar artery while inflating the balloon appropriate.The force was no longer transmitted to the balloon and the shaft was found broken.Another wire was inserted to the plantar artery and through into a 2.0x80mm non-bsc balloon.The non-bsc balloon was inflated and the system was completely removed from the patient's body.
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