BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY
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Model Number F6QA252RT |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6).
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Event Description
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It was reported that an unknown patient underwent atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a webster¿ electrophysiology catheter.The catheter shaft broke.During an avnrt procedure, while advancing the mapping catheter to the patient's heart, the catheter shaft broke and could not be situated in the patient's heart.A similar catheter was open and the procedure continue and ended successfully.No patient consequences.The damage did not result in wires being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The sheath was a 6f.The catheter shaft breaking while inside of the patient is mdr-reportable.
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Manufacturer Narrative
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On 2-oct-2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 22-oct-2021, the product investigation was completed.It was reported that an unknown patient underwent atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a webster¿ electrophysiology catheter.The catheter shaft broke.During an avnrt procedure, while advancing the mapping catheter to the patient's heart, the catheter shaft broke and could not be situated in the patient's heart.A similar catheter was open and the procedure continue and ended successfully.No patient consequences.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the webster 4 pole.A manufacturing record evaluation was performed for the finished device 30485262m number, and no internal actions elated to the reported complaint condition were identified.The event described could not be confirmed as the as the device was found in good conditions.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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