BIOSENSE WEBSTER INC LASSO® NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
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Model Number D134903 |
Device Problems
Signal Artifact/Noise (1036); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a premature ventricular contraction procedure with a lasso® nav eco catheter, and the biosense webster, inc.Product analysis lab observed a lasso loop broken issue.Initially the lasso® nav eco catheter (lot 30499595l) had a signal noise which occurred at the 7-8, 9-10 on both the carto 3 system and the lab2 when placed in the patient¿s body.The cable was reconnected and changed but the issue continued.The lasso® nav eco catheter was changed and the issue resolved.The procedure could be continued and completed without patient consequence.The signal noise issue was assessed as not mdr reportable.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2021 the returned sample revealed damage at the tip area on the lasso® nav eco catheter as internal components were exposed and electrodes 1 and 2 were forcefully moved from their original place.Multiple attempts have been made to obtain clarification to this returned condition.However, no further information has been made available.This returned condition was assessed as mdr reportable for a lasso loop broken issue.The awareness date for this reportable lab finding was (b)(6) 2021.
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Manufacturer Narrative
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(b)(6).The bwi product analysis lab received the device for evaluation 03-sep-2021.The device evaluation was completed on (b)(6) 2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned sample revealed damage at the tip area on the lasso nav eco catheter, internal components were exposed and electrodes 1 and 2 were forcefully moved from their original place.A follow-up activity was opened to verify if it was a pre-existing condition and no response was returned, therefore it's possible that this damage was done to the catheter after the procedure by an unknown force, possibly by poor handling of the device but this cannot be conclusively determined.The electrical test could not be performed as the damage done to the catheter's electrodes made it unable to further analyze it.A manufacturing record evaluation was performed and no internal action was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.To minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
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