BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139505 |
Device Problems
Image Orientation Incorrect (1305); 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 01/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation on 15-feb-2024.The device evaluation was completed on 05-mar-2024.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 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 screening test was performed and the device was recognized correctly; however, hi force appeared due to an internal printed circuit board (pcb) issue.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed and no internal actions was found during the review.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: to ensure accurate force readings, verify that the force reading is near zero when the device is not in contact with tissue.If the force reading is not near zero when the device is not in contact with tissue, perform zeroing.If the force problem persists, replace the device cable or the device.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.Explanation of codes: -investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿force vector was inverted and inaccurate force readings¿ issues.-investigation findings: incompatible component/ accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the customer¿s reported ¿force vector was inverted and inaccurate force readings¿ issues.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 (afib) procedure with a qdot micro catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.The force vector was inverted and there were inaccurate force readings on the carto 3 system.The caller re-zeroed the catheter but the issue persisted.The cable was new, so they did not replace the cable.When the catheter was replaced, the issue was resolved.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 05-mar-2024, observed reddish material and a hole in the pebax.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 05-mar-2024 and have assessed this returned condition as reportable.
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Search Alerts/Recalls
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