BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139401 |
Device Problems
Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E: 1.Initial reporter phone:(b)(4).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent a cardiac ablation ablation procedure with a qdot micro¿ catheter and an insufficient irrigation issue occurred when 90w was applied.No adverse patient consequence was reported.
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Manufacturer Narrative
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It was reported that a patient underwent a cardiac ablation ablation procedure with a qdot micro¿ catheter and an insufficient irrigation issue occurred when 90w was applied.No adverse patient consequence was reported.The qdot micro¿ device was returned to biosense webster (bwi) for evaluation.Visual inspection and temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed char on the dome.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Explanation of codes: investigation findings: contamination of environment by device (c1503) / investigation conclusions: cause not established (d15) / component code: electrode ((b)(4)) were selected as related to the char found on the dome.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported irrigation issue.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On (b)(6) 2024, the device evaluation was updated as follows: it was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and an insufficient irrigation issue occurred when 90w was applied.No adverse patient consequence was reported.The qdot micro device was returned to biosense webster (bwi) for evaluation.Visual inspection and temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed char on the dome.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed, and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.Char is a physical phenomenon of radiofrequency.It can be the usual result of the ablation process.The instructions for use contain the following instructions: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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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