ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Perforation of Esophagus (2399); Cardiac Perforation (2513); Heart Block (4444)
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Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported esophageal perforation, cardiac perforation, heart block, stroke, and hemorrhaging remain unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.Concomitant devices: therapy¿ ablation catheter, flexability¿ ablation catheter, flexability¿ ablation catheter, sensor enabled¿, tacticath¿ contact force ablation catheter, sensor enabled¿, therapy dual 8¿ ablation catheter (therapy dual 8 is captured under therapy ablation product line).
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Event Description
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Related manufacturing ref: 3008452825-2024-00003,3008452825-2024-00004.3008452825-2024-00005, 3008452825-2024-00007, 3008452825-2024-00008.Abbott ep eu mdr feasibility report: ablation catheters.Background: a retrospective observational study was conducted to assess the long-term safety and effectiveness outcomes on abbott¿s ablation catheters, specifically therapy and therapy dual 8, tacticath se, flexability, and flexability se, using data from the pinc aitm healthcare database (phd), a comprehensive u.S hospital chargemaster database.In the study, device information was extracted using sting search from the chargemaster data in phd, incidence rates for safety endpoints up to 12 months post- procedure were calculated.The safety endpoints included cardiac perforation/tamponade, major bleeding, stroke/transient ischemic attack (tia), and heart block with cardiac rhythm management.Additionally, effectiveness in treating arrhythmias including af, svt, and vt were evaluated by calculating the incidence of recurrence, which was captured by primary diagnosis codes of the arrhythmia in the data.The following complications occurred: six events of aef within 30 days (of those only five were from tacticath ablation catheter); nine events of stroke/tia within 7 days (of those only eight were from tacticath ablation catheter); seventy events of cardiac perforation/tamponade within 30 days (of those only sixty were from tacticath ablation catheter); forty-three events of heart block w/ crm implant within 7 days (of those only thirty were from tacticath ablation catheter); twenty- eight events of major bleeding within 7 days (of those only twenty-six were from tacticath ablation catheter).
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Search Alerts/Recalls
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