BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139402 |
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 Type
malfunction
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Manufacturer Narrative
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The device evaluation was completed on 21-dec-2023.The qdot micro device was returned to biosense webster (bwi) for evaluation.A 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 features were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The blood found inside the pebax area may contribute to the force issue reported.A manufacturing record evaluation was performed and no internal action was found during the review.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.Manufacturer¿s reference number: (b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure with a qdot micro which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.The system showed a "streaming error contact force" and could not show any force value.The error stayed after changing the cable.After changing the catheter, the error was gone immediately.The catheter was exchanged before any ablation was conducted.No patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 21-dec-2023, reddish material and a hole in the pebax was observed.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 21-dec-2023 and have assessed this returned condition as reportable.
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Manufacturer Narrative
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Additional information was received on 22-jan-2024.The actual user was unknown.Therefore, provided contact details for the director, univ.Hospital clinic for rhythmology.Therefore, updated section "e.Initial reporter".Initial reporter title: prof.Dr.Initial reporter phone: (b)(6) 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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