PHILIPS IMAGE GUIDED THERAPY CORPORATION ANGIOSCULPT EVO RX PTCA; CATHETER, PTCA, CUTTING/SCORING
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Model Number 2200-2020-B |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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The patient's dob or age at time of event, gender, weight, 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.Foreign: (b)(6).The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system.
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Event Description
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The angiosculpt device was used in a moderately tortuous and moderately calcified rca.After inflation/deflation and upon removal, the angiosculpt got stuck on the guide wire, thus were removed as a unit.Outside of the patient, the guidewire was dislodged from the angiosculpt and reinserted into the patient.The procedure was completed with a non-angiosculpt device.No patient injury reported.This adverse event is being reported because the angiosculpt got stuck on a non-manufacturer's guide wire and removed as a unit.Placement of a new guide wire was necessary to complete the procedure.
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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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