BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139504 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The magnetic and force feature were tested, and no errors were observed.However, screening test could not be performed due to occlusion.Further investigation revealed that the irrigation holes in the dome section were occluded with crystalized saline solution.The reddish material found inside the pebax area may have contributed to the force issue reported.The root cause of the hole in the pebax could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number 31172439l, and no internal actions were identified.The issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.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.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 an atrial fibrillation procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a reddish material and a hole in the pebax.Initially, it was reported that during the procedure, when on q mode plus, the force would jump and fluctuate dramatically.There were no error codes nor messages.They continued to oscillate between q mode and q mode plus without resolution.When the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The force issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 12-jan-2024, there was reddish material and a hole in the pebax.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 12-jan-2024.
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Search Alerts/Recalls
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