BIOSENSE WEBSTER INC EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
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Model Number BD7TCDF4L |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that an unknown patient underwent an avnrt ablation procedure with a ez steer¿ bi-directional electrophysiology catheter.It was reported by the bwi representative that when the catheter was removed from the box, one of the sides of the sterile packaging seal was open.The catheter was replaced, and the issue was resolved.No patient consequences were reported.Open pouch seal is mdr-reportable.
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Manufacturer Narrative
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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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 3-nov-2022, bwi received confirmation that the catheter was not used on the patient.On 16-nov-2022, the product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed.A manufacturing record evaluation was performed for finished device number 30402406m and no internal actions related to the reported complaint condition were identified.The analysis could not be performed due to pouch was not returned for analysis.Therefore, the event described could not be confirmed.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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