BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING
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Catalog Number D7BTCFL252RT |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that prior to a patient's ablation procedure, the medical team discovered that the celsius¿ electrophysiology catheter they had intended to use had a physical abnormality at the catheter's distal end.The physician identified the following issue through the packing window: there was a ridge/hump at the catheter's tip (proximal to electrodes).The device was not used on the patient.No further details were provided.
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Manufacturer Narrative
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The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 reference number: pc-(b)(4).
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Manufacturer Narrative
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On 1-feb-2024, the product investigation was completed.It was reported that prior to a patient's ablation procedure, the medical team discovered that the celsius¿ electrophysiology catheter they had intended to use had a physical abnormality at the catheter's distal end.The physician identified the following issue through the packing window: there was a ridge/hump at the catheter's tip (proximal to electrodes).The device was not used on the patient.No further details were provided.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.The device was returned in its original packaging.The packaging was opened, then the device was removed from the pouch to perform a visual inspection and no damage or anomalies were observed.A manufacturing record evaluation was performed for the finished device number lot 30977305m and no internal actions related to the complaint were found during the review.The issue reported by the customer was not confirmed, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The issue identified by the customer is the anchor pin and that it is part of the catheter design.As part of the 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 reference number: (b)(4).
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Manufacturer Narrative
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On 12-jan-2024, the bwi product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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