Catalog Number 0684-00-0575 |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter full name: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint # (b)(4).
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Event Description
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It was reported that during the insertion of an intra-aortic balloon (iab), the sheath became damaged.There was no reported injury to the patient.
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Manufacturer Narrative
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The introducer dilator and sheath assembly were returned with traces of blood on the exterior.No other components returned.A visual evaluation determined that the sheath was damaged at the tip.The sheath was determined to be frayed, confirming the reported problem.However, we are unable to determine how this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).
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Event Description
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It was reported that during the insertion of an intra-aortic balloon (iab), the sheath became damaged.There was no reported injury to the patient.
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Manufacturer Narrative
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Additional information: unique identifier (udi): (b)(4).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Reference complaint (b)(4).
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Event Description
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It was reported that during the insertion of an intra-aortic balloon (iab), the sheath became damaged.There was no reported injury to the patient.
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Manufacturer Narrative
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Additional information.Section h evaluation method codes added: historical data analysis; 4109.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint (b)(4).H3 other text : device not returned.
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Event Description
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It was reported that during the insertion of an intra-aortic balloon (iab), the sheath became damaged.There was no reported injury to the patient.
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Search Alerts/Recalls
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