BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number H749165993012 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that the sterile package was torn.An impulse guide catheter was selected for use.During unpacking, it was noted that the sterile packing housing the three diagnostic catheters were torn in such a way that the catheters were no longer considered sterile.This happened on 5 separate occasions and in each time another 3-pack was opened and the procedure was completed.The device was not inserted into the patient.No patient complications were reported.
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Search Alerts/Recalls
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