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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Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 h3: device evaluated by mfg = other (81) -device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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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The holder was not flushed prior to attempting to remove the wire guide from the holder.The procedure was complete by using another wire guide.
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Search Alerts/Recalls
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