Catalog Number 0684-00-0513 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Event site postal code: (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 record id # (b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon(iab), the balloon could not be advanced into the blood vessel, and the use was discontinued.Treatment was continued with another iab catheter.There was no reported injury to the patient.
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Event Description
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It was reported during insertion of the intra-aortic balloon(iab), the balloon could not be advanced into the blood vessel, and the use was discontinued.Treatment was continued with another iab catheter.There was no reported injury to the patient.
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Manufacturer Narrative
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Additional information evaluation method codes (4): 4109 & 4115.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 discarded and not returned.
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Search Alerts/Recalls
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