ST. JUDE MEDICAL, INC. INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number IBI-87008 |
Device Problems
Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2022 |
Event Type
malfunction
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Event Description
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During the atrial fibrillation procedure, following insertion of the catheter into the left atrium, the loop portion of the catheter was caught on the straight shaft and could not be removed.Attempts to straighten the catheter and remove it were unsuccessful.The catheter was able to bend depending on the method, but could not be straightened.It was also noted that the catheter could not be inserted into the sheath due to strong flexion.The catheter was pulled out from the left atrial septum to the right atrium, and the loop was not entangled.The catheter was taken in and out or rotated multiple times in the right atrium, and finally it could be stored in the sheath.When checked outside the body, the catheter was noted to be bent, could not be straightened and the loop was entwined.When the catheter was pulled out from the left atrium to the right atrium, the loop remained entwined with a possible atrial septal defect (asd).The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
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Manufacturer Narrative
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One duodecapolar, double loop, inquiry afocusii diagnostic catheter was received for evaluation.The catheter deflected when actuating the steering mechanism; however, the catheter no longer was able to return to a straightened position and no longer met specifications, due to a kink in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kink and the reported entanglement issue remains unknown.
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