Model Number D134805 |
Device Problems
Complete Blockage (1094); Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 ref.# (b)(4).
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Event Description
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a clot issue was encountered.It was reported that right after opening the thermocool® smart touch® sf bi-directional navigation catheter saline could be flushed as normal, but it was only temporarily placed in the patient¿s body with an ablation catheter, after which it became unable to flush.It was unknown whether there was a thrombus block or not, but the physician commented that blood was likely to clot because activated clotting time (act) was slightly low, however, char /coagulum/thrombus/clot was not observed.The event occurred before ablation, right after it was inserted into the patient¿s body.The procedure was completed by changing the catheter.The procedure was completed without patient's consequence.This event will be conservatively considered as a thrombus/clot issue since it was reported that ¿the blood was likely to clot because act was slightly low.¿.
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Manufacturer Narrative
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a clot issue was encountered.It was reported that right after opening the thermocool® smart touch® sf bi-directional navigation catheter saline could be flushed as normal, but it was only temporarily placed in the patient¿s body with an ablation catheter, after which it became unable to flush.It was unknown whether there was a thrombus block or not, but the physician commented that blood was likely to clot because activated clotting time (act) was slightly low, however, char /coagulum/thrombus/clot was not observed.The event occurred before ablation, right after it was inserted into the patient¿s body.The procedure was completed by changing the catheter.The procedure was completed without patient's consequence.Device evaluation details: the thermocool® smart touch® sf bi-directional navigation catheter was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection, temperature and impedance test, cool flow pump, and pressure gage test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the catheter.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.Then, during the irrigation test, it was observed the catheter was not irrigating correctly.The catheter was dissected, in accordance with bwi procedures.The irrigation tube was found occluded with reddish brown material.The ¿no irrigation¿ issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed and no internal action was found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s suspected thrombus/clot.Investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the occluded irrigation.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 26-july-2022, additional information was received indicating the procedure was completed without affecting the patient.No clots were confirmed, but it was suspected that clots were the cause of the blockage of the irrigation hole.There was no char /coagulum/thrombus/clot observed.On, (b)(6) 2022, 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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