BIOSENSE WEBSTER INC LASSOSTAR NAV CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Catalog Number D140401 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation details: the lassostar nav circular mapping catheter was returned to biosense webster inc for evaluation and the evaluation has been completed.Bwi conducted a visual inspection test of the returned device.The device was visually inspected and was found the shaft was broken in the middle section with electrical wires exposed, however, this damage was not reported by the customer.A manufacturing record evaluation was performed and no internal action was found during the review.No customer complaint was not confirmed since no malfunction was initially reported.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's (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 lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified the shaft was broken in the middle section with electrical wires exposed.It was initially reported there this lassostar nav circular mapping catheter was stuck within a heliostar catheter but there was no reported problems with the lassostar nav circular mapping catheter.The customer reported event was not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6)-2023, the bwi pal revealed that a visual inspection of the returned device found found the shaft was broken in the middle section with electrical wires exposed.These findings were reviewed and assessed these to be an mdr reportable malfunction.
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 27-nov-2023, it was noticed the incorrect h6.Medical device problem code was reported in the 3500a initial medwatch report.The incorrect code reported was "adverse event without identified device or use problem (a24).The correct code is "device-device incompatibility (a1702)" and the field has been appropriately updated.
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Search Alerts/Recalls
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