BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 45006 |
Device Problems
Mechanical Problem (1384); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2021 |
Event Type
malfunction
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Event Description
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It was reported a loss of rotation occurred.A 1.6mm jetstream sc atherectomy catheter was used over a thruway guidewire in an urgent rotational atherectomy procedure.The jetstream catheter was advanced; however, when reaching a critical point of the lesion, the catheter did not advance, showing a loss of rotation, and consequently was unable to progress completely into the lesion.The physician tried multiple times without success, the results were not as expected.
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Manufacturer Narrative
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Device/media analysis: the jetstream sc-1.6 device was received by boston scientific for analysis.The shaft and the remainder of the device were inspected for damage.Visual examination showed multiple bends on the catheter shaft as well as buckling/kinks located 8.5cm from the tip to proximal 16.5cm.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed as designed.There were no issues with running the device.The device activated and was run for a period of 2 minutes with no issues or errors.Inspection of the remainder of the device revealed no other damage or irregularities.The event of blades not spinning (loss of rotation) was not confirmed.
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Event Description
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It was reported a loss of rotation occurred.A 1.6mm jetstream sc atherectomy catheter was used over a thruway guidewire in an urgent rotational atherectomy procedure.The jetstream catheter was advanced; however, when reaching a critical point of the lesion, the catheter did not advance, showing a loss of rotation, and consequently was unable to progress completely into the lesion.The physician tried multiple times without success, the results were not as expected.
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Search Alerts/Recalls
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