PHILIPS IMAGE GUIDED THERAPY CORPORATION ANGIOSCULPT EVO RX PTCA; CATHETER, PTCA, CUTTING/SCORING
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Model Number 2200-3015-B |
Device Problems
Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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The patient's ethnicity and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Attempts to obtain the information has not been successful.The angiosculpt device was returned for evaluation.Visual inspection found a distal bond peel with one leaflet lifted, but remained intact to the device.During functional testing, a laboratory asahi sion blue 0.014" coated guide wire was activated with saline and inserted through the distal tip and through the device, with slight resistance.After balloon inflation/deflation, with slight resistance the guide wire was removed from the device.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.
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Event Description
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The angiosculpt device was used to treat the proximal rca and upon removal, the balloon got pinned to the wire and had to be removed as a unit.The balloon was inflated 3 times to 18 atm (rbp is 16 atm).No issues observed or reported during delivery.The lesion was rewired without complications to complete the procedure.No patient injury reported.During the returned device analysis, a distal bond peel was observed.This adverse event is being submitted because the angiosculpt and guidewire were removed as a unit.Placement of a new guide wire was necessary to complete the procedure.In addition, this product problem is being submitted because the distal bond peeled, potential for harm if it were to recur.
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Manufacturer Narrative
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Blocks d1/ g1: manufacturer name and site name were updated from spectranetics to philips image guided therapy corporation to match the information on the product label.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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Search Alerts/Recalls
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