Catalog Number RFSPC-035145-0-I-AQ |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: phone - (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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As reported, before an unspecified procedure, the tip of the roadrunner nimble hydrophilic wire guide separated.The device did not make patient contact.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.
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Manufacturer Narrative
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Additional information: b5, d9, h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional information was received 27mar2024.The wire guide holder was not flushed prior to attempted removal of the wire guide.The procedure was completed with an unspecified wire guide.
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Search Alerts/Recalls
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