ST. JUDE MEDICAL, INC. THERAPY ABLATION CATHETER QUADRIPOLAR, MEDIUM CURVE 7F; CARDIAC ABLATION PERCUTANEOUS CATHETER
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Model Number IBI-83365 |
Device Problems
Material Frayed (1262); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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During the procedure, the catheter was inserted in the usual fashion via arterial sheath.Upon advancement to and from the heart, the catheter looped around itself.The catheter was straightened out successfully and pulled out of the sheath.It was noted that the coating on the shaft had been damaged, which both prevented the deflection mechanism from functioning properly and exposed internal catheter components.The ablation catheter was replaced with a flexibility ablation catheter to complete the procedure with no adverse patient consequences.
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Manufacturer Narrative
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One quadripolar, therapy ablation catheter was received for evaluation.The reported torn shaft, withdrawal difficulty, deflection issue, and exposed internal components were confirmed.The catheter shaft was noted to be torn, exposing the internal components of the catheter and interfering with the ability to deflect.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the torn shaft remains unknown.
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Search Alerts/Recalls
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