Model Number H802228240022 |
Device Problems
Peeled/Delaminated (1454); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/24/2014 |
Event Type
malfunction
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Event Description
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It was reported that a mild flaking/peeling of the wire occurred.The target lesion was located in the left anterior descending artery.A 330cm rotawire was selected.While introducing a 1.25mm rotalink burr, while still external to the patient, it was noted that the burr was not advancing smoothly on the wire.A mild flaking/peeling of the rotawire was observed.The rotawire was exchanged for another wire and the procedure was completed.There were no patient complications reported and the patient's status is stable.
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Manufacturer Narrative
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Age at time of event: 18 years and older.(b)(4).
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Event Description
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It was reported that a mild flaking/peeling of the wire occurred.The target lesion was located in the left anterior descending artery.A 330cm rotawire¿ was selected.While introducing a 1.25mm rotalink burr, while still external to the patient, it was noted that the burr was not advancing smoothly on the wire.A mild flaking/peeling of the rotawire was observed.The rotawire was exchanged for another wire and the procedure was completed.There were no patient complications reported and the patient's status is stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for evaluation.Device analysis noted that the body and the distal end were kinked.Furthermore, it was noted that the spring tip was bent.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Search Alerts/Recalls
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