BIOSENSE WEBSTER, INC. (JUAREZ) HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
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Model Number D-1160-43-S |
Device Problems
Knotted (1340); Difficult to Remove (1528); Failure to Read Input Signal (1581); Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: terumo pinnacle 10cm 7fr short sheath, model and lot numbers unknown.Manufacturer's ref.No: (b)(4).
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Event Description
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It was reported that a patient underwent a procedure for supraventricular tachycardia with a halo catheter where the catheter became knotted.During the procedure, the catheter became knotted, and was found to be difficult to remove from the patient's body.It appeared that the catheter was stuck in a partially deflected state.The physician was able to manipulate the hand controls, but the catheter would not respond to the inputs.A second catheter was used to assist in the removal of the knotted catheter.The procedure then continued with a new catheter, and the case was completed without patient consequence.There was no obvious damage to the catheter or electrodes noted upon withdrawal.The sheath in use was a terumo pinnacle 10cm short sheath (7fr).The issue with the deflection mechanism is not reportable.Since a catheter with this issue cannot deflect or relax completely, it cannot be used and must be replaced.The potential that this could cause or contribute to an adverse event is remote.However, the issue with the catheter becoming knotted is an mdr reportable event.Even if the integrity of the catheter is intact and no rings appear to be damaged or sharp, there is still a significant risk of damage to the patient's vascular structures.
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Manufacturer Narrative
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On (b)(4) 2017, the bwi failure 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.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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Manufacturer's reference number: (b)(4).It was reported that a patient underwent a procedure for supraventricular tachycardia with a halo catheter where the catheter became knotted.The returned device was visually inspected, and was found in good condition.Per the reported event, a deflection test was performed, which the catheter passed.The catheter outer diameter was measured, and was found within specification.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.
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Search Alerts/Recalls
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