BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139505 |
Device Problems
Material Puncture/Hole (1504); 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 10/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and post procedure the bwi product analysis lab identified a hole in the pebax.During the initial ablation, the contact force increased from 10g to 60g.The cable and the qdot micro catheter were replaced with new ones, and the issue was resolved.The procedure was completed without patient's consequence.
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Manufacturer Narrative
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The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.The magnetic and force feature was tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed, however, the reddish material inside the pebax could be related to the force issue reported by the customer.A manufacturing record evaluation was performed for the finished device batch number 31077594l, and no internal actions were identified.The issue reported by the customer was confirmed.Product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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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