BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D128208 |
Device Problem
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 12/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.There was clot on the pentaray when it was removed from the patient.The catheter was replaced.The procedure continued.No patient consequences were reported.Thrombus/clot is mdr-reportable.
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Manufacturer Narrative
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On 8-feb-2022, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30658467l and no internal action related to the complaint was found during the review.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 (b)(6) 2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.There was clot on the pentaray when it was removed from the patient.The catheter was replaced.The procedure continued.No patient consequences were reported.Device evaluation details: visual analysis revealed thrombus attached to the tip of the device, additionally, some electrodes were bent.A patency test was performed, and irrigation could not be performed, therefore, dissection was performed in the shaft area and the irrigation tube was found folded, the root cause of the thrombus issue reported by the customer could be related to this failure.The root cause of the bent electrodes and the bent irrigation tube could not be conclusively determined, but it was concluded that it most likely occurred during the procedure, outside of the bwi manufacturing facilities.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 30658467l, and no internal action was found during the review.The issue reported by the customer was 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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Manufacturer Narrative
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On (b)(6) 2022, 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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