BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING
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Model Number NS7TCFL174HS |
Device Problems
Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a navistar¿ electrophysiology catheter and a white dusty powder was found on the handle of the catheter.When the sterile bag was opened, a white dusty powder was found on the handle of the catheter.The issue was resolved by replacing the navistar catheter to another new one.The device was not used on the patient.The foreign material was loose with movement.The procedure was completed without patient's consequence.
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Manufacturer Narrative
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The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.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.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.E1.Initial reporter phone: (b)(6).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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Manufacturer Narrative
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It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a navistar¿ electrophysiology catheter and a white dusty powder was found on the handle of the catheter.When the sterile bag was opened, a white dusty powder was found on the handle of the catheter.The issue was resolved by replacing the navistar catheter to another new one.The device was not used on the patient.The foreign material was loose with movement.The procedure was completed without patient's consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.According to pictures provided by the customer, apparently dust particles were seen inside the catheter connector, however, during the analysis in the lab, a visual inspection revealed no damage or anomalies on the device.No white dusty powder was found on the handle of the catheter.Microscopic examination of the connector was performed and no issue was observed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.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 ref.#: (b)(4).
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Manufacturer Narrative
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On 14-sep-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
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Search Alerts/Recalls
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