BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7312 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(6).Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks on the hypotube at 23cm and 26.5cm from the hub.Microscopic examination revealed a kink to the inflation lumen and guidewire lumen 42mm from the tip.There is a hole in the guidewire lumen 19mm from the tip and it appears to be consistent with guidewire puncturing it.There is blood present in the guidewire lumen and balloon.There is contrast present in the inflation lumen and the balloon is loosely folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.A.014" test guide wire was advanced into the guide wire lumen and was able to pass thru.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that froze on wire occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 5.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, after locking up with the guidewire, it could not be removed.Both balloon and guidewire were simply removed together from the patient's body.The procedure was completed with a non bsc balloon catheter.No patient serious injury or adverse event were reported.
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