BIOSENSE WEBSTER INC LASSOSTARNAV,10P,15MM DIA LOOP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Catalog Number D140401 |
Device Problems
Material Separation (1562); Communication or Transmission Problem (2896); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostarnav,10p,15mm dia loop and the catheter fell apart.It was reported that the lassostarnav catheter fell apart and is currently stuck inside the cryo balloon.The catheter was replaced.There was no patient consequences.
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Manufacturer Narrative
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Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device 30981727l number, and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).On 3-jan-2024, iit was noticed the following information was inadvertently omitted from the 3500a initial mdr: "resistance was felt during retraction of the catheter.Damage resulted in wire exposure and the device was not used with the heliostar catheter.Also, the device was also not being recognized by the carto 3 system.They tried 20-b and also replacing the dongle but the issue is still there." as such, h6.Medical device problem code of "communication or transmission problem (a13) has been added.
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Search Alerts/Recalls
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