C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
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Model Number 006173P |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the customer mentioned about material rupture , detachment of device or device component and failure to capture issues in the temporary pacing electrode catheter.It was stated that there were no clinical signs symptoms or conditions, but there was a surgical intervention.
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Manufacturer Narrative
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Upon further review, bd has determined that there was no allegation against the product.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the customer mentioned about material rupture , detachment of device or device component and failure to capture issues in the temporary pacing electrode catheter.It was stated that there were no clinical signs symptoms or conditions, but there was a surgical intervention.
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Search Alerts/Recalls
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