Model Number AC-1059590 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3.Date of event: exact event date is unknown.
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Event Description
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It was reported that during a procedure, the laser fibers broke.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
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Manufacturer Narrative
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B3.Date of event: exact event date is unknown.G2.Report source: correction.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber did not confirm the reported broken laser fiber event.Visual analysis did not identify any defect.The fiber was inside an unopened box.The box was opened to reveal the fiber was inside, with no anomaly.According to the device instruction for use (ifu), the ifu states: do not use if the sterile packaging is torn or punctured.Do not use if labeling is incomplete or illegible.Do not use if the fiber is not sterile.The use of a non-sterile fiber may cause cross-contamination to the patient.Do not use if there is evidence of damage or wear that may compromise function.To avoid damage to the optical fiber and fiber delivery device, do not use the fiber when the bend radius is less than 40 mm.If the bend radius is less than 40 mm fiber the following may occur: energy from the fiber tip may suddenly drop and the fiber may break to due heat buildup at the bending spot.Based on the analysis result and information available, there was no fiber break found during analysis.The information reasonably suggests that a fiber with no defect is unlikely to cause patient harm.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
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Event Description
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It was reported that during a procedure, the laser fibers broke.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
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Search Alerts/Recalls
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